FDA 510(k) Application Details - K040193

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

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510(K) Number K040193
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant MEDICAL EQUIPMENT DEVICE SPECIALISTS
9811 W. CHARLESTON #2387
LAS VEGAS, NV 89117 US
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Contact C.A. TEKLINSKI
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 01/28/2004
Decision Date 04/27/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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