
Microtek Medical, Inc. an Ecolab Company
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SURGICAL LIGHT HANDLE COVER is an FDA 510(k)-cleared medical device (K133554) manufactured by Microtek Medical, Inc. an Ecolab Company. 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 April 7, 2014. Regulation: 8.