510(k) K965162 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.
| Applicant | Lukens Medical Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Feb 12, 1997 |
| Received | Dec 24, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965162
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2024 | SURGICAL SPECIALTIES POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N Open, Classified |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.