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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 K201868
Device Name Phyziofit Medical Surgical Mask
Applicant
Wellpower Sporting Goods Co., Ltd.
# 12, Xinglong New St., Quantang Industrial Zone,
Liaobu Town
Dongguan,  CN 523425
Applicant Contact Carol Tseng
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Rm. 2012#, Gebu Commercial Bldg., Hongxing Community
Songgang St.
Shenzhen,  CN 518105
Correspondent Contact Mar Liu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/07/2020
Decision Date 02/22/2021
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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