← Product Code [MGP](/productcode/MGP) · K953618

# SPYROFLEX WOUND DRESSING (K953618)

_Polymedica Industries, Inc. · MGP · Aug 21, 1995 · SU · SN_

**Canonical URL:** https://fda-staging.innolitics.com/device/K953618

## Device Facts

- **Applicant:** Polymedica Industries, Inc.
- **Product Code:** [MGP](/productcode/MGP.md)
- **Decision Date:** Aug 21, 1995
- **Decision:** SN
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU

---

**Source:** [https://fda-staging.innolitics.com/device/K953618](https://fda-staging.innolitics.com/device/K953618)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com