510(k) K112549 ยท FRO Dressing, Wound, Drug
IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
| Applicant | Covalontechnologies, Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, May 4, 2012 |
| Received | Sep 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112549
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.