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510(k) K052611

ECP HEALTH SYSTEM, MODEL 2005 by Ecp Health, Inc. — Product Code DRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2006
Date Received
September 22, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Counter-Pulsating, External
Device Class
Class II
Regulation Number
870.5225
Review Panel
CV
Submission Type

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