K920368 is an FDA 510(k) clearance for the ULCUFLEX HYDROCOLLOID PASTE. This device is classified as a Bandage, Liquid (Class I - General Controls, product code KMF).
Submitted by Industrias Palex C/O Dma Med-Chem Corp. (Postal: Apartado 1940, ES). The FDA issued a Cleared decision on March 26, 1992, 58 days after receiving the submission on January 28, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5090.
| 510(k) Number | K920368 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 1992 |
| Decision Date | March 26, 1992 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KMF — Bandage, Liquid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5090 |