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510(k) K173483

Pure Flow External Counter-Pulsation Device by Xtreem Pulse, LLC — Product Code DRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2018
Date Received
November 13, 2017
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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