510(k) K905135 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
LAPAROTOMY SPONGES
| Applicant | American Healthcare Corp., Canada, CA |
| Decision | Substantially Equivalent, Mar 6, 1991 |
| Received | Nov 15, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905135
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.