K120958 is an FDA 510(k) clearance for the POSISEP AND POSISEP X HEMOSTAT DRESSINGS. This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.
Submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on July 25, 2012, 117 days after receiving the submission on March 30, 2012.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K120958 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2012 |
| Decision Date | July 25, 2012 |
| Days to Decision | 117 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. |