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510(k) K042413

ACS MODEL NCP-2 by Applied Cardiac Systems — Product Code DRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2004
Date Received
September 7, 2004
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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