FDA 510(k) Application Details - K013094

Device Classification Name Device, Discharge, Electrostatic (For Pain Relief)

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510(K) Number K013094
Device Name Device, Discharge, Electrostatic (For Pain Relief)
Applicant ORTHOSONIX, INC.
615 7TH ST. NE
1ST FLOOR
WASHINGTON, DC 20002 US
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Contact RUSSELL PAGANO
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Regulation Number 000.0000

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Classification Product Code NHH
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Date Received 09/17/2001
Decision Date 12/14/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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