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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 K090042
Device Name PAINMASTER MCT PATCH
Applicant
Newmark, Inc.
919 Eighteenth St. NW
Suite 600
Washington,  DC  20006
Applicant Contact DEBORAH LIVORNESE
Correspondent
Newmark, Inc.
919 Eighteenth St. NW
Suite 600
Washington,  DC  20006
Correspondent Contact DEBORAH LIVORNESE
Regulation Number882.5890
Classification Product Code
NUH  
Date Received01/06/2009
Decision Date 05/06/2009
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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