510(k) K160271 ยท MSH Respirator, Surgical
N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
| Applicant | San-M Package Co., Ltd., Shimada-City, JP |
| Decision | Substantially Equivalent, Jul 15, 2016 |
| Received | Feb 2, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K160271
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.