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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K151995
Device Name Painmaster MCT Patch
Applicant
NEWMARK, INC.
131 Quarry Road
Cheshire,  CT  06410
Applicant Contact Francis Powell
Correspondent
M SQUARED ASSOCIATES, INC.
575 8th, Suite 1212
New York,  NY  10018
Correspondent Contact Cherita James
Regulation Number882.5890
Classification Product Code
NUH  
Date Received07/20/2015
Decision Date 10/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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