The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Comfeel Ulcus Sheet.
| Device ID | K840438 |
| 510k Number | K840438 |
| Device Name: | COMFEEL ULCUS SHEET |
| Classification | Dressing, Wound, Drug |
| Applicant | COLOPLAST A/S 200 W. 7TH. STREET SUITE 1512 Fort Worth , TX 76102 - |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer COLOPLAST A/S 200 W. 7TH. STREET SUITE 1512 Fort Worth , TX 76102 - |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-01 |
| Decision Date | 1984-11-07 |