K944163 is an FDA 510(k) clearance for the SPECTRUM DISIGNS PECTORAL IMPLANT, a Implant, Muscle, Pectoralis (Class II — Special Controls, product code MIC), submitted by Spectrum Designs, Inc. (Goleta, US). The FDA issued a Cleared decision on November 7, 1994, 73 days after receiving the submission on August 26, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K944163 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 26, 1994 |
| Decision Date | November 07, 1994 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MIC — Implant, Muscle, Pectoralis |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.3620 |