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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 BUILDING NO.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 BUILDING NO.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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