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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Counter-Pulsating, External
510(k) Number K023427
Device Name CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
Applicant
CARDIOMEDICS, INC.
18872 BARDEEN AVE.
IRVINE,  CA  92612
Applicant Contact GARY CLARK
Correspondent
CARDIOMEDICS, INC.
18872 BARDEEN AVE.
IRVINE,  CA  92612
Correspondent Contact GARY CLARK
Regulation Number870.5225
Classification Product Code
DRN  
Date Received10/11/2002
Decision Date 01/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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