K052504 is an FDA 510(k) clearance for the GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X, a Elastomer, Silicone Block (Class II — Special Controls, product code MIB), submitted by Implantech Associates, Inc. (Ventura, US). The FDA issued a Cleared decision on November 4, 2005, 52 days after receiving the submission on September 13, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K052504 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 13, 2005 |
| Decision Date | November 04, 2005 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MIB — Elastomer, Silicone Block |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.3620 |