
Suncoast Medical Manufacturers, Inc.
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SURG-A-STAT LOOP TIP 2 is an FDA 510(k)-cleared medical device (K840387) manufactured by Suncoast Medical Manufacturers, 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 July 22, 1984. Regulation: 8.