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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 K152852
Device Name ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
Applicant
BAYER HEALTHCARE, LLC
100 BAYER BOULEVARD
WHIPPANY,  NJ  07981 -0915
Applicant Contact William R Walsh
Correspondent
BAYER HEALTHCARE, LLC
100 BAYER BOULEVARD
WHIPPANY,  NJ  07981 -0915
Correspondent Contact William R Walsh
Regulation Number882.5890
Classification Product Code
NUH  
Date Received09/29/2015
Decision Date 12/22/2015
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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