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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 K002750
Device Name HL168T
Applicant
Health & Life Co., Ltd.
6f,#407, Chung Shan Rd.
Sec.02, Chung Ho City
Taipei Hsien,  TW 235
Applicant Contact PAUL YANG
Correspondent
Health & Life Co., Ltd.
6f,#407, Chung Shan Rd.
Sec.02, Chung Ho City
Taipei Hsien,  TW 235
Correspondent Contact PAUL YANG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/05/2000
Decision Date 09/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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