K133121 is an FDA 510(k) clearance for the CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT, a Hemostatic Wound Dressing Without Thrombin Or Other Biologics, submitted by Sam Medical Products (Wilsonville, US). The FDA issued a Cleared decision on May 22, 2014, 234 days after receiving the submission on September 30, 2013. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K133121 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 30, 2013 |
| Decision Date | May 22, 2014 |
| Days to Decision | 234 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. |