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510(k) K030532

CPCA2000 COUNTERPULSATION SYSTEM by Cpca2000, Inc. — Product Code DRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2003
Date Received
February 19, 2003
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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