510(k) K101128 ยท OUK Surgical Mask With Antimicrobial/Antiviral Agent
BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
| Applicant | Filligent Limited, Austin TX, US |
| Decision | Substantially Equivalent, May 26, 2011 |
| Received | Apr 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101128
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.