K183622 is an FDA 510(k) clearance for the NasalCEASE and BleedCEASE. This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.
Submitted by Les Laboratoires Brothier S.A. (Nanterre, FR). The FDA issued a Cleared decision on December 2, 2019, 341 days after receiving the submission on December 26, 2018.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K183622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2018 |
| Decision Date | December 02, 2019 |
| Days to Decision | 341 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. |