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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K112796
Device Name SURGICAL GOWN (EO STERILIZED)
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 Number878.4040
Classification Product Code
FYA  
Date Received09/26/2011
Decision Date 09/12/2013
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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