510(k) K121919 ยท KKX Drape, Surgical, Antimicrobial
SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
| Applicant | Exact Medical Manufacturing, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Feb 14, 2013 |
| Received | Jul 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121919
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.