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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 K214035
Device Name LAITEST Medical Face Mask
Applicant
R&R Medical Corporation, Ltd.
#4, Ln. 38, Zhongxing N. St., Sanchong Dist.,
New Taipei City,  TW 24158
Applicant Contact Wilson Chang
Correspondent
Voler Biotech Consulting CO., Ltd.
# 3-1, Lane 58, Hejiang St., Zhongshan Disy.
Taipei City,  TW 10480
Correspondent Contact Chih Hao Kao
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/23/2021
Decision Date 09/13/2022
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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