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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 K872034
Device Name CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM
Applicant
Cardiomedics, Inc.
19401 S. Vermont Ave. (B-
100)
Torrance,  CA  90502
Applicant Contact Joseph J Schwoebel
Correspondent
Cardiomedics, Inc.
19401 S. Vermont Ave. (B-
100)
Torrance,  CA  90502
Correspondent Contact Joseph J Schwoebel
Regulation Number870.5225
Classification Product Code
DRN  
Date Received05/27/1987
Decision Date 09/18/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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