FDA 510(k) Application Details - K032928

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

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510(K) Number K032928
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant MEDIPHYSICS PAIN CENTERS OF AMERICA
13 ORCHARD ROAD
UNIT 108
LAKE FOREST, CA 92630 US
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Contact JAMES ROGERS
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 09/22/2003
Decision Date 12/19/2003
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 Y
Expedited Review



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