510(k) K963128 ยท MDA Elastomer, Silicone, For Scar Management
NOVAGEL SILICONE GEL SHEETING
| Applicant | Brennen Medical, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Dec 5, 1996 |
| Received | Aug 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963128
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.