The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Comfeel Ulcus Ulcer Care System.
| Device ID | K873669 |
| 510k Number | K873669 |
| Device Name: | COMFEEL ULCUS ULCER CARE SYSTEM |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-11 |
| Decision Date | 1987-11-17 |