
Kunshan Jiehong Nonwoven Product Co., Ltd.
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TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE is an FDA 510(k)-cleared medical device (K112136) manufactured by Kunshan Jiehong Nonwoven Product Co., Ltd.. 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 September 28, 2011. Regulation: 8.