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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
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
NHH
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More FDA Info for this Product Code
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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