510(k) K972634 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
ULTRACELL SUCTION SPONGE
| Applicant | Ultracell Medical Technologies, Inc., North Stonington CT, US |
| Decision | Substantially Equivalent, Dec 17, 1997 |
| Received | Jul 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972634
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.