INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE

INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE is an FDA 510(k)-cleared medical device (K013225) manufactured by Medafor, Inc.. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 25, 2001. Regulation: 8.