K102944 is an FDA 510(k) clearance for the CORELEADER HEMO-PAD MODEL CPII 02030, a Hemostatic Wound Dressing Without Thrombin Or Other Biologics, submitted by Coreleader Biotech Co., Ltd. (Taipei, Taiwan, TW). The FDA issued a Cleared decision on September 7, 2011, 338 days after receiving the submission on October 4, 2010. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K102944 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 04, 2010 |
| Decision Date | September 07, 2011 |
| Days to Decision | 338 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. |