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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 K202532
Device Name Disposable Surgical Gowns
Applicant
Anhui Medpurest Medical Technology Co.,Ltd
#188,Wenyuan Rd., Zhumeng New Zone
Anqing,  CN 246003
Applicant Contact Long Shushan
Correspondent
Shanghai Sungo Management Consulting Company Limited.
13th Floor, 1500# Central Ave.
Shangghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/01/2020
Decision Date 08/21/2021
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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