510(k) K121819 ยท FRO Dressing, Wound, Drug
SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
| Applicant | Covalontechnologies, Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, Aug 13, 2012 |
| Received | Jun 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121819
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.