K874276 is an FDA 510(k) clearance for the CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER. This device is classified as a Expander, Surgical, Skin Graft (Class I - General Controls, product code FZW).
Submitted by Cox-Uphuff Intl. (Santa Barbara, US). The FDA issued a Cleared decision on December 2, 1987, 43 days after receiving the submission on October 20, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K874276 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1987 |
| Decision Date | December 02, 1987 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FZW — Expander, Surgical, Skin Graft |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |