K865033 is an FDA 510(k) clearance for the BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER. This device is classified as a Tissue Expander And Accessories.
Submitted by Cox-Uphuff Intl. (Carpinteria, US). The FDA issued a Cleared decision on January 12, 1987, 20 days after receiving the submission on December 23, 1986.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K865033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1986 |
| Decision Date | January 12, 1987 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | LCJ — Tissue Expander And Accessories |
| Device Class | — |