
Ultracision, Inc.
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ULTRACISON HARMONIC SCALPEL HS2 BLADE is an FDA 510(k)-cleared medical device (K941897) manufactured by Ultracision, 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 June 30, 1994. Regulation: 8.