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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 K171599
Device Name WiTouch Pro, WiTouch, Neubac
Applicant
Hollywog LLC
2830 Amnicola Highway
chattanooga,  TN  37406
Applicant Contact michael treas
Correspondent
Hollywog LLC
2830 Amnicola Highway
chattanooga,  TN  37406
Correspondent Contact michael treas
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NYN  
Date Received06/01/2017
Decision Date 09/22/2017
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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