510(k) K161013 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
InnoSEAL Hemostatic Pad
| Applicant | Innotherapy, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Nov 29, 2016 |
| Received | Apr 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161013
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.