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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.
Rm. 201, Shunfeng Bldg., #109 Hongxing Rd.,
Qiaonan Block
Hangzhou,  CN 311215
Applicant Contact Yaya Lu
Correspondent
Hangzhou Runheng Medical Co., Ltd.
Rm. 201, Shunfeng Bldg., #109 Hongxing Rd.,
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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