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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 K213736
Device Name Medical Face Mask
Applicant
Hangzhou Runheng Medical Co., Ltd.
Room 201, Shunfeng Building, NO.109 Hongxing Road,
Qiaonan Block
Hangzhou,  CN 311215
Applicant Contact Yaya Lu
Correspondent
Hangzhou Runheng Medical Co., Ltd.
Room 201, Shunfeng Building, NO.109 Hongxing Road,
Qiaonan Block
Hangzhou,  CN 311215
Correspondent Contact Yaya Lu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received11/29/2021
Decision Date 03/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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