← Product Code [KOZ](/submissions/SU/subpart-e%E2%80%94surgical-devices/KOZ) · K870941

# PHARMASEAL WOUND CARE DRESSING PAD (K870941)

_American Pharmaseal Div. Ahsc · KOZ · Mar 27, 1987 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOZ/K870941

## Device Facts

- **Applicant:** American Pharmaseal Div. Ahsc
- **Product Code:** [KOZ](/submissions/SU/subpart-e%E2%80%94surgical-devices/KOZ.md)
- **Decision Date:** Mar 27, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4018
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon). This classification does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOZ/K870941](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOZ/K870941)

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