510(k) K040004 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
ORTHOCORD SUTURE
| Applicant | Depuy Mitek, Norwood MA, US |
| Decision | Substantially Equivalent, Apr 13, 2004 |
| Received | Jan 2, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040004
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2009 | Ethicon, Inc. Orthocord Suture, DePuy Mitek, a Johnson & Johnson Company; . DePuy Mitek, Inc.
325 Paramount Drive, Raynham, MA 02767
Sutures are intended for general soft tissue approximation and/or ligation. Terminated |
NEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.