FDA 510(k) Application Details - K992709

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

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510(K) Number K992709
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant 138 MEDICAL SUPPLIES, INC.
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 08/11/1999
Decision Date 11/09/1999
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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