FDA 510(k) Application Details - K153704

Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief

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510(K) Number K153704
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant DJO, LLC
1430 DECISION ST.
VISTA, CA 92081 US
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Contact Rand Daoud
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 12/23/2015
Decision Date 06/03/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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