K983792 is an FDA 510(k) clearance for the SEARE BIOMEDICAL SILICONE TISSUE EXPANDER. This device is classified as a Tissue Expander And Accessories.
Submitted by Seare Biomedical Corp. (Salt Lake City, US). The FDA issued a Cleared decision on December 11, 1998, 45 days after receiving the submission on October 27, 1998.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K983792 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1998 |
| Decision Date | December 11, 1998 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LCJ — Tissue Expander And Accessories |
| Device Class | — |