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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K082542
Device Name ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A
Applicant
CARDICARE COMPANY, LTD.
9 YAN AN ROAD, WU SHAN PLAZA
TOWN, UNIT 7003
HANGZHOU, ZHEJIANG,  CN 310002
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received09/03/2008
Decision Date 09/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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