510(k) K972597 ยท MDA Elastomer, Silicone, For Scar Management
PMT NEW BEGINNINGS GELSHAPES & AMEND
| Applicant | Pmt Corp., Chanhassen MN, US |
| Decision | Substantially Equivalent, Oct 1, 1997 |
| Received | Jul 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972597
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.