510(k) K101097 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
CALGAESEAL MODEL: CAS
| Applicant | Bz Medical, Inc., Portland OR, US |
| Decision | Substantially Equivalent, Sep 22, 2010 |
| Received | Apr 20, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101097
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.