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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K190269
Device Name PureLift
Applicant
Xtreem Pulse, LLC
353 W. 29 St., Suite 3
New York,  NY  10001
Applicant Contact Andrew Berile
Correspondent
IUVO Consulting, LLC
PO Box 56436
Virginia Beach,  VA  23456
Correspondent Contact Rhonda Alexander
Regulation Number882.5890
Classification Product Code
NFO  
Date Received02/08/2019
Decision Date 08/28/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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