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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 K212861
Device Name Surgical Gown, Reinforced Surgical Gown
Applicant
Wuhan Zonsen Medical Products Co.,Ltd
No.8 Jinchao Road Zhucheng Street Xinzhou District
Wuhan,  CN 431400
Applicant Contact Cynthia Ye
Correspondent
Shanghai Sungo Management Consulting Company Limited
14 th Floor, 1500# Central Avenue
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/08/2021
Decision Date 12/15/2021
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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