510(k) K123481 ยท FRO Dressing, Wound, Drug
AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
| Applicant | Convatec, Inc., Skillman NJ, US |
| Decision | Substantially Equivalent, Jun 6, 2013 |
| Received | Nov 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123481
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2022 | ConvaTec, Inc ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive Open, Classified |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.