510(k) K964846 ยท MDA Elastomer, Silicone, For Scar Management
IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
| Applicant | Implantech Associates, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Feb 12, 1997 |
| Received | Dec 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964846
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.