510(k) K993157 ยท FZP Clip, Implantable
HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240
| Applicant | Weck Closure Systems, Research Triangle Park NC, US |
| Decision | Substantially Equivalent, Dec 17, 1999 |
| Received | Sep 21, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993157
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2012 | Teleflex Medical Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709.
Teleflex Medicals Hem-o-lok polymer ligating clips are single use, sterile, Terminated |
FZP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.