510(k) K112800 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
SUNTOUCH TOPICAL HEMOSTATIC DRESSING
| Applicant | Huizhou Foryou Medical Devices Co., Ltd., Pennington NJ, US |
| Decision | Substantially Equivalent, May 23, 2012 |
| Received | Sep 27, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112800
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2015 | Coreva Health Science LLC ActCel
advanced bleeding control
Topical Hemostatic Dressing
2in X 2in (5cm X 5cm)
4in X 4in
Sterile Contents
Soluble Regenerated Cellulose
For Bleeding Control
For external topical and temporary us Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.