K883303 is an FDA 510(k) clearance for the MENTOR RAPID-SPAN (TM) TISSUE EXPANDER. This device is classified as a Expander, Surgical, Skin Graft (Class I - General Controls, product code FZW).
Submitted by Mentor Corp. (Goleta, US). The FDA issued a Cleared decision on August 26, 1988, 22 days after receiving the submission on August 4, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K883303 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1988 |
| Decision Date | August 26, 1988 |
| Days to Decision | 22 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 |