The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Comfeel(r) Wound Dressing Sd.
| Device ID | K925376 |
| 510k Number | K925376 |
| Device Name: | COMFEEL(R) WOUND DRESSING SD |
| Classification | Bandage, Liquid |
| Applicant | COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-23 |
| Decision Date | 1993-03-16 |