K112800 is an FDA 510(k) clearance for the SUNTOUCH TOPICAL HEMOSTATIC DRESSING. This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.
Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Pennington, US). The FDA issued a Cleared decision on May 23, 2012, 239 days after receiving the submission on September 27, 2011.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K112800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2011 |
| Decision Date | May 23, 2012 |
| Days to Decision | 239 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QSY — Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
| Device Class | — |
| Definition | To Temporarily Control Bleeding And Cover External Wounds. |