510(k) K903029 ยท GAR Suture, Nonabsorbable, Synthetic, Polyamide
STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE
| Applicant | Look, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Oct 25, 1990 |
| Received | Jul 10, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K903029
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2011 | Surgical Specialties Corp SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle.
Intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular Terminated |
DTH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.