510(k) K941197 ยท MDA Elastomer, Silicone, For Scar Management
SILK*SKIN SCAR TREATMENT
| Applicant | Puritas Health Care, Inc., New Milford CT, US |
| Decision | Substantially Equivalent, Aug 11, 1994 |
| Received | Mar 14, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941197
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.