K080097 is an FDA 510(k) clearance for the MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET. This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.
Submitted by Medtrade Products , Ltd. (Crewe, GB). The FDA issued a Cleared decision on July 9, 2008, 177 days after receiving the submission on January 14, 2008.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K080097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 2008 |
| Decision Date | July 09, 2008 |
| Days to Decision | 177 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. |