
Gm Engineering, Inc.
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ARTICULATING RETRACTOR TISSUE RETRACTORS is an FDA 510(k)-cleared medical device (K953348) manufactured by Gm Engineering, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 11, 1995. Regulation: 8.