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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 K112378
Device Name COBES SURGICAL DRAPE
Applicant
Cobes Industries Co., Ltd.
3500 S. Dupont Hwy.
Dover,  DE  19901
Applicant Contact LEON LU
Correspondent
Cobes Industries Co., Ltd.
3500 S. Dupont Hwy.
Dover,  DE  19901
Correspondent Contact LEON LU
Regulation Number878.4370
Classification Product Code
KKX  
Date Received08/18/2011
Decision Date 05/08/2012
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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