510(k) K162362 ยท FRG Wrap, Sterilization
PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator
| Applicant | Pms Tibbi Cihazlar Teknolojisi San VE Tic AS, Mersin, TR |
| Decision | Substantially Equivalent, Oct 13, 2017 |
| Received | Aug 23, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162362
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.