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FDA 510(k) Application Details - K030827
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K030827
Device Name
Neurological Stereotaxic Instrument
Applicant
ORTHOSOFT, INC.
75 QUEEN ST., SUITE 3300
MONTREAL, QUEBEC H3C 2N6 CA
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Contact
CHRISTOPHER MCLEAN
Other 510(k) Applications for this Contact
Regulation Number
882.4560
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Classification Product Code
HAW
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More FDA Info for this Product Code
Date Received
03/14/2003
Decision Date
05/23/2003
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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