← Product Code [FRO](/productcode/FRO) · K952907

# EX-111 WOUND DRESSING (K952907)

_Variseal Manufacturing Corp. · FRO · Aug 7, 1995 · SU · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K952907

## Device Facts

- **Applicant:** Variseal Manufacturing Corp.
- **Product Code:** [FRO](/productcode/FRO.md)
- **Decision Date:** Aug 7, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU

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**Source:** [https://fda-staging.innolitics.com/device/K952907](https://fda-staging.innolitics.com/device/K952907)

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