510(k) K964398 ยท MGP Dressing, Wound And Burn, Occlusive
SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED
| Applicant | Polymedica Industries, Inc., Golden, CO, US |
| Decision | Substantially Equivalent, Oct 24, 1997 |
| Received | Nov 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964398
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.