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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Counter-Pulsating, External
510(k) Number K173483
Device Name Pure Flow External Counter-Pulsation Device
Applicant
Xtreem Pulse, LLC
353 W. 29 St. Suite 3
New York,  NY  10001
Applicant Contact Andrew Barile
Correspondent
Iuvo Consulting, LLC
1820 Perla Dr.
Virginia Beach,  VA  23456
Correspondent Contact Rhonda Alexander
Regulation Number870.5225
Classification Product Code
DRN  
Date Received11/13/2017
Decision Date 05/30/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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