QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER

QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER is an FDA 510(k)-cleared medical device (K911369) manufactured by Deroyal Industries, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 12, 1991. Regulation: 8.