510(k) K970416 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
ACUFEX DOUBLE ARMED SUTURE NEEDLE
| Applicant | Smith & Nephew Endoscopy, Inc., Mansfield MA, US |
| Decision | Substantially Equivalent, Apr 21, 1997 |
| Received | Feb 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970416
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.