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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, for pain relief
510(k) Number K120398
Device Name WITOUCH PRO
Original Applicant
HOLLYWOG, LLC
2830 ammicola highway
chattanooga,  TN  37406
Original Contact michael w treas
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
NYN  
Date Received02/08/2012
Decision Date 08/16/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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