The following data is part of a premarket notification filed by Richard Hamer Assoc., Inc. with the FDA for Comfeel Plus Pressure Relief Dressing.
| Device ID | K951325 |
| 510k Number | K951325 |
| Device Name: | COMFEEL PLUS PRESSURE RELIEF DRESSING |
| Classification | Protector, Skin Pressure |
| Applicant | RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 -0598 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 -0598 |
| Product Code | FMP |
| CFR Regulation Number | 880.6450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-23 |
| Decision Date | 1995-07-31 |