The following data is part of a premarket notification filed by Richard Hamer Assoc., Inc. with the FDA for Comfeel Plus Wound Dressing.
| Device ID | K941263 |
| 510k Number | K941263 |
| Device Name: | COMFEEL PLUS WOUND DRESSING |
| Classification | Bandage, Liquid |
| Applicant | RICHARD HAMER ASSOC., INC. 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
| Contact | Max Furimsky |
| Correspondent | Max Furimsky RICHARD HAMER ASSOC., INC. 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-16 |
| Decision Date | 1994-05-10 |