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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 K130114
Device Name PAINMASTER MCT PATCH
Applicant
Newmark, Inc.
901 King St., Suite 101
Alexandria,  VA  22314
Applicant Contact CHERITA JAMES
Correspondent
Newmark, Inc.
901 King St., Suite 101
Alexandria,  VA  22314
Correspondent Contact CHERITA JAMES
Regulation Number882.5890
Classification Product Code
NUH  
Date Received01/16/2013
Decision Date 04/16/2013
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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