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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
510(k) Number K133080
Device Name Plus Surgical Drapes (EO Sterilized), PMDB-XXX
Applicant
Foshan Nanhai Plus Medical Co, Ltd.
3500 S. Dupont Hwy.
Dover,  DE  19901
Applicant Contact LEON LU
Correspondent
Foshan Nanhai Plus Medical Co, Ltd.
3500 S. Dupont Hwy.
Dover,  DE  19901
Correspondent Contact LEON LU
Regulation Number878.4370
Classification Product Code
KKX  
Date Received09/30/2013
Decision Date 06/24/2015
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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