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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 K141467
Device Name SURGICAL GOWN
Applicant
Xuchang Zhengde Environstar Medical Products Co.,L
7th Foor Jingui Business Bldg. #982
Congym Rd. Baiym District
Guangzhou, Guangdong,  CN 510420
Applicant Contact MIKE GU
Correspondent
Xuchang Zhengde Environstar Medical Products Co.,L
7th Foor Jingui Business Bldg. #982
Congym Rd. Baiym District
Guangzhou, Guangdong,  CN 510420
Correspondent Contact MIKE GU
Regulation Number878.4040
Classification Product Code
FYA  
Date Received06/03/2014
Decision Date 03/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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