510(k) K212971 ยท OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus
NPseal
| Applicant | Guard Medical, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Feb 10, 2022 |
| Received | Sep 17, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212971
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.