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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K201754
Device Name JianYu Surgical Mask
Applicant
Jiangsu Jianyu Health Medical Co., Ltd.
# 88 Longxi Ave., Zhulin Town, Jintan District
Changzhou,  CN 213241
Applicant Contact Andy Shu
Correspondent
Jiangsu Jianyu Health Medical Co., Ltd.
# 88 Longxi Ave., Zhulin Town, Jintan District
Changzhou,  CN 213241
Correspondent Contact Andy Shu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/29/2020
Decision Date 12/30/2020
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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