510(k) K933811 ยท MDA Elastomer, Silicone, For Scar Management
MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST
| Applicant | Pitt Enterprises (Silicone) , Ltd., New Millford CT, US |
| Decision | Substantially Equivalent, May 12, 1994 |
| Received | Aug 4, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K933811
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.