510(k) K231953 ยท FRO Dressing, Wound, Drug
Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)
| Applicant | Coloplast Corp., Plymouth MN, US |
| Decision | Substantially Equivalent, Mar 22, 2024 |
| Received | Jun 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231953
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.