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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K060835
Device Name HL888SF
Applicant
Health & Life Co., Ltd.
9f, # 186 Jian Yi Rd.,
Zhonghe District, New Taipei City,  TW 23553
Applicant Contact ALEX KOU
Correspondent
Health & Life Co., Ltd.
9f, # 186 Jian Yi Rd.,
Zhonghe District, New Taipei City,  TW 23553
Correspondent Contact ALEX KOU
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/27/2006
Decision Date 04/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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