510(k) K080818 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING
| Applicant | Hem Con Medical Technologies, Inc., Portland OR, US |
| Decision | Substantially Equivalent, May 15, 2008 |
| Received | Mar 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080818
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.