K070211 is an FDA 510(k) clearance for the TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM, a Hemostatic Wound Dressing Without Thrombin Or Other Biologics, submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on April 5, 2007, 73 days after receiving the submission on January 22, 2007. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K070211 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 22, 2007 |
| Decision Date | April 05, 2007 |
| Days to Decision | 73 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. |