510(k) K112961 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
CLO-SURPLUS P.A.D.
| Applicant | Scion Cardio-Vascular, Inc., Melbourne FL, US |
| Decision | Substantially Equivalent, Oct 31, 2011 |
| Received | Oct 4, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112961
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.