KOOL GARD SINGLES GOWN

KOOL GARD SINGLES GOWN is an FDA 510(k)-cleared medical device (K952114) manufactured by American Threshold Industries, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 24, 1995. Regulation: 8.