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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 K052611
Device Name ECP HEALTH SYSTEM, MODEL 2005
Applicant
Ecp Health, Inc.
8416 Prairie Rose Ln.
Fort Worth,  TX  76123
Applicant Contact SHAMON HUANG
Correspondent
Ecp Health, Inc.
8416 Prairie Rose Ln.
Fort Worth,  TX  76123
Correspondent Contact SHAMON HUANG
Regulation Number870.5225
Classification Product Code
DRN  
Date Received09/22/2005
Decision Date 04/26/2006
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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