510(k) K082518 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
DUAL NEEDLE SUTURE PASSER SYSTEM
| Applicant | Cayenne Medical, Inc., Scottsdale AZ, US |
| Decision | Substantially Equivalent, Jan 16, 2009 |
| Received | Sep 2, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082518
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.