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FDA 510(k) Application Details - K012937
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K012937
Device Name
Neurological Stereotaxic Instrument
Applicant
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
826 COAL CREEK CIR.
LOUISVILLE, CO 80027 US
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Contact
VICTORIA G RENDON
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
HAW
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More FDA Info for this Product Code
Date Received
08/31/2001
Decision Date
01/25/2002
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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