AMER. SURGICAL CORP. EXTRA PLUS PAK

AMER. SURGICAL CORP. EXTRA PLUS PAK is an FDA 510(k)-cleared medical device (K841738) manufactured by American Surgical Co., Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 1984. Regulation: 8.