← Product Code [FMP](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMP) · K951325

# COMFEEL PLUS PRESSURE RELIEF DRESSING (K951325)

_Richard Hamer Assoc., Inc. · FMP · Jul 31, 1995 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMP/K951325

## Device Facts

- **Applicant:** Richard Hamer Assoc., Inc.
- **Product Code:** [FMP](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMP.md)
- **Decision Date:** Jul 31, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6450
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Regulatory Identification

A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores).

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMP/K951325](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMP/K951325)

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