510(k) K990090 ยท GAR Suture, Nonabsorbable, Synthetic, Polyamide
DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE
| Applicant | Aesculap, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 22, 1999 |
| Received | Jan 11, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990090
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2014 | Aesculap, Inc. Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding Terminated |
GAR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.