FDA 510(k) Application Details - K171599

Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter

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510(K) Number K171599
Device Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant Hollywog LLC
2830 Amnicola Highway
Chattanooga, TN 37406 US
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Contact Michael Treas
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Regulation Number 882.5890

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Classification Product Code NUH
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Date Received 06/01/2017
Decision Date 09/22/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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