510(k) K955165 ยท EFQ Gauze/Sponge, Internal
SYNTHETIC SPONGE
| Applicant | Igenics, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Feb 5, 1996 |
| Received | Nov 13, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955165
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.