
Medical Assoc. Intl., Inc.
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MAI STERILE UTILITY DRAPE is an FDA 510(k)-cleared medical device (K853347) manufactured by Medical Assoc. Intl., 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 4, 1985. Regulation: 8.