510(k) K101000 ยท FXX Mask, Surgical
WELLMIEN SURGICAL MASK
| Applicant | Wellmien (Suzhou) Import & Export Trading Co., Ltd., Pennington NJ, US |
| Decision | Substantially Equivalent, Aug 9, 2010 |
| Received | Apr 12, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K101000
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.