K873669 is an FDA 510(k) clearance for the COMFEEL ULCUS ULCER CARE SYSTEM. This device is classified as a Dressing, Wound, Drug.
Submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on November 17, 1987, 67 days after receiving the submission on September 11, 1987.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K873669 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | September 11, 1987 |
| Decision Date | November 17, 1987 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |