510(k) K052504 ยท MIB Elastomer, Silicone Block
GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
| Applicant | Implantech Associates, Inc., Ventura CA, US |
| Decision | Substantially Equivalent, Nov 4, 2005 |
| Received | Sep 13, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052504
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.