K973730 is an FDA 510(k) clearance for the DURASIL I AND DURASIL II, a Elastomer, Silicone Block (Class II — Special Controls, product code MIB), submitted by Hanson Medical, Inc. (Seattle, US). The FDA issued a Cleared decision on December 24, 1997, 85 days after receiving the submission on September 30, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K973730 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 30, 1997 |
| Decision Date | December 24, 1997 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MIB — Elastomer, Silicone Block |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.3620 |