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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 Rd., Wu Shan Plaza
Town, Unit 7003
Hangzhou, Zhejiang,  CN 310002
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. 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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