AMCON SLIP IN MYDRIATIC SUNGLASSES

AMCON SLIP IN MYDRIATIC SUNGLASSES is an FDA 510(k)-cleared medical device (K942407) manufactured by Amcon Laboratories, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 5, 1994. Regulation: 8.