K983043 is an FDA 510(k) clearance for the SEARE BIOMEDICAL SILICONE BLOCK, a Implant, Muscle, Pectoralis (Class II — Special Controls, product code MIC), submitted by Seare Biomedical Corp. (Salt Lake City, US). The FDA issued a Cleared decision on September 30, 1998, 30 days after receiving the submission on August 31, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K983043 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 31, 1998 |
| Decision Date | September 30, 1998 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MIC — Implant, Muscle, Pectoralis |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.3620 |