
Wallach Surgical Devices, Inc.
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WALLACH COLD SOAKER is an FDA 510(k)-cleared medical device (K910491) manufactured by Wallach Surgical Devices, 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 May 20, 1991. Regulation: 8.