510(k) K212198 ยท FRG Wrap, Sterilization
Tyvek(R) Roll with CI for STERLINKTM Sterilizer
| Applicant | Plasmapp Co,., Ltd., Daejeon, KR |
| Decision | Substantially Equivalent, Oct 22, 2021 |
| Received | Jul 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212198
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.