FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird-like figure with three curved lines representing wings or feathers. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN - 5 1998 Ms. Gladynell Rodriguez Quality Assurance Supervisor Customed, Incorporated Calle Iqualdad #7 Fajardo, Puerto Rico 00738 Re : K974647 Fanfold Drape 41" X 57" Product No. 900-633, Trade Name: Recorder No. 0633 Requlatory Class: II Product Code: KKX Dated: December 10, 1997 Received: December 12, 1997 Dear Ms. Rodriguez: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions -The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {1}------------------------------------------------ Page 2 - Ms. Rodriguez through 542 of the Act for devices under the Electronic Chrough J42 OF the not in provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as first reed in your 510 (k) premarket notification. The FDA described in your fial equivalence of your device to a legally Finding of bubbeanded organesults in a classification for your marketed predicate actre your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy M. Ulatowski Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/3 description: The image contains a sequence of handwritten digits and symbols. The sequence starts with a symbol that resembles a stylized 'K', followed by the digits '9', '7', '4', '6', '4', and '7'. The digits are written in a clear, legible manner, and the overall impression is that of a handwritten numerical code or identifier. Image /page/2/Picture/4 description: The image shows the word "CUSTOMED" in a bold, sans-serif font. The letters are black and appear to be outlined. The word is slightly curved, giving it a dynamic appearance. The overall design is simple yet eye-catching. EXHIBIT 11 510 (K) Number (If Known) : N/A Device Name : Fanfold Drape (Surgical Drape) 41"x57" Intended use: The surgical drape is used as a protective patient covering such as to isolate a side of surgical incision from microbial and other contamination. ( PLEASE DO NOT WRITE BELLOW THIS LINE-CONTINUE ON NOTHER PAGE IF NEEDE (Division Sign-Off) ্রামের ম P4D Division of Dontal, In and General Ford F OFFICE OF DEVICE EVALUATION (ODE) 510(k) Number OR OVER THE COUNTER USE PRESCRIPTION USE (PER 21 CFR 801.109)