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510(k) K152115

Renew NCP-5 External Counterpulsation System by Stage 2 Innovations — Product Code DRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2015
Date Received
July 29, 2015
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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