510(k) K041704 ยท MDA Elastomer, Silicone, For Scar Management
NEWGEL AND NEWGEL PLUS E
| Applicant | Newmedical Technology, Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, Oct 17, 2005 |
| Received | Jun 23, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041704
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.