510(k) K982941 ยท FZP Clip, Implantable
HEM-O-LOK MODEL NUMBERS 523900, 523970
| Applicant | Weck Closure Systems, Research Triangle Park NC, US |
| Decision | Substantially Equivalent, Nov 19, 1998 |
| Received | Aug 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982941
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2004 | Weck Hem-o-LokSMX Legating Clip, REF 544220, Lot 988384, Non-absorbable Polymer Ligation Clips, Sterile EO, Weck Closure Systems, Research Triangle Park, NC 27709, Sterile, Single use, Disposable. Terminated |
FZP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.