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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 K222456
Device Name High Protection Surgical Gown
Applicant
3A Medical Products Co., Ltd
Yuan Industrial Park
Liuan,  CN 237100
Applicant Contact Amy Ma
Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4040
Classification Product Code
FYA  
Date Received08/15/2022
Decision Date 03/12/2023
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
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