510(k) K971075 ยท EFQ Gauze/Sponge, Internal
PRIMED PRIME-PLUS COTTON GAUZE SPONGES
| Applicant | Primeline Medical Products, Inc., Alberta, CA |
| Decision | Substantially Equivalent, Jun 22, 1997 |
| Received | Mar 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971075
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.