K894916 is an FDA 510(k) clearance for the COMFEEL TRANSPARENT DRESSING. This device is classified as a Tape And Bandage, Adhesive (Class I - General Controls, product code KGX).
Submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on September 26, 1989, 55 days after receiving the submission on August 2, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K894916 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 1989 |
| Decision Date | September 26, 1989 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KGX — Tape And Bandage, Adhesive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5240 |