K951325 is an FDA 510(k) clearance for the COMFEEL PLUS PRESSURE RELIEF DRESSING. This device is classified as a Protector, Skin Pressure (Class I - General Controls, product code FMP).
Submitted by Richard Hamer Assoc., Inc. (Fort Worth, US). The FDA issued a Cleared decision on July 31, 1995, 130 days after receiving the submission on March 23, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6450.
| 510(k) Number | K951325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1995 |
| Decision Date | July 31, 1995 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMP — Protector, Skin Pressure |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6450 |