FDA 510(k) Application Details - K030140

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

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510(K) Number K030140
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant DUOMED INC.
400 NORTHPOINT PARKWAY #406
WEST PALM BEACH, FL 33407 US
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Contact CHARLES KOKINOS
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 01/14/2003
Decision Date 03/18/2003
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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