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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K112136
Device Name TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
Applicant
Kunshan Jiehong Nonwoven Product Co., Ltd.
1340 W Pennsylvania Ave.
San Diego,  CA  92103
Applicant Contact Glen Feye
Correspondent
Kunshan Jiehong Nonwoven Product Co., Ltd.
1340 W Pennsylvania Ave.
San Diego,  CA  92103
Correspondent Contact Glen Feye
Regulation Number878.4370
Classification Product Code
KKX  
Date Received07/26/2011
Decision Date 09/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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