510(k) K980617 ยท GDW Staple, Implantable
MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER
| Applicant | Urohealth Systems, Inc., Richland MI, US |
| Decision | Substantially Equivalent, Apr 9, 1998 |
| Received | Jan 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980617
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.