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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 K120500
Device Name THE PAIN PILOT (A.K.A PAIN PILOT)
Applicant
Hollywog, LLC
2830 Amnicola Hwy.
Chattanooga,  TN  37406
Applicant Contact MICHAEL W TREAS
Correspondent
Hollywog, LLC
2830 Amnicola Hwy.
Chattanooga,  TN  37406
Correspondent Contact MICHAEL W TREAS
Regulation Number882.5890
Classification Product Code
NUH  
Date Received02/21/2012
Decision Date 08/20/2012
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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