SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL

SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL is an FDA 510(k)-cleared medical device (K103770) manufactured by Syntex Healthcare Products Co., Ltd.. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 20, 2011. Regulation: 8.