K063190 is an FDA 510(k) clearance for the SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC. This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.
Submitted by Noble Fiber Technologies, Inc. (Scranton, US). The FDA issued a Cleared decision on August 21, 2007, 305 days after receiving the submission on October 20, 2006.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K063190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2006 |
| Decision Date | August 21, 2007 |
| Days to Decision | 305 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. |