510(k) K971597 ยท NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
| Applicant | Coloplast Corp., Fort Worth TX, US |
| Decision | Substantially Equivalent, Jul 29, 1997 |
| Received | May 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971597
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.