
Customed, Inc.
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GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) is an FDA 510(k)-cleared medical device (K971920) manufactured by Customed, 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 December 3, 1997. Regulation: 8.