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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 K010261
Device Name CARDIOMEDICS ECP SYSTEM
Applicant
Cardiomedics, Inc.
18872 Bardeen Ave.
Irvine,  CA  92612
Applicant Contact JOHN HUTCHINS
Correspondent
Cardiomedics, Inc.
18872 Bardeen Ave.
Irvine,  CA  92612
Correspondent Contact JOHN HUTCHINS
Regulation Number870.5225
Classification Product Code
DRN  
Date Received01/29/2001
Decision Date 02/28/2001
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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