510(k) K905482 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE
| Applicant | Pfizer Hospital Products Group, Inc., Fall River MA, US |
| Decision | Substantially Equivalent, Mar 14, 1991 |
| Received | Dec 6, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905482
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2010 | Telefelx Medical Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+BG BR 3-0 DSL 19 1N (45cm), Teleflex Medical. Bondek and Bondek Plus Synthetic Absorbable Surgical Sutures intended uses are in gener Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.