510(k) K160595 ยท FRG Wrap, Sterilization
PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator
| Applicant | Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti, Mersin, TR |
| Decision | Substantially Equivalent, Nov 18, 2016 |
| Received | Mar 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160595
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.