510(k) K861308 ยท EFQ Gauze/Sponge, Internal
ACCUPAC CUSTOM PACK KERLIX SQUARES
| Applicant | Geneva Laboratories, Inc., Elkhorn WI, US |
| Decision | Substantially Equivalent, May 2, 1986 |
| Received | Apr 8, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861308
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.