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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 K171802
Device Name ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
Applicant
Bayer HealthCare LLC
100 Bayer Boulevard
Whippany,  NJ  07981 -0915
Applicant Contact Cindy R. Abraham
Correspondent
Bayer HealthCare LLC
100 Bayer Boulevard
Whippany,  NJ  07981 -0915
Correspondent Contact Verna Mecadon
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NYN  
Date Received06/19/2017
Decision Date 03/07/2018
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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