510(k) K991191 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
| Applicant | Genzyme Surgical Product (Genzyme Biosurgery), Fall River MA, US |
| Decision | Substantially Equivalent, Jun 22, 1999 |
| Received | Apr 8, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991191
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2010 | Telefelx Medical Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+VI R 0 HRX27 1N (70 cm), Teleflex Medical. Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.