510(k) K981322 ยท GAR Suture, Nonabsorbable, Synthetic, Polyamide
CUTALON NYLON POLYAMIDE SURGICAL SUTURE
| Applicant | Genzyme Surgical Product (Genzyme Biosurgery), Fall River MA, US |
| Decision | Substantially Equivalent, Jul 7, 1998 |
| Received | Apr 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981322
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.