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FDA 510(k) Application Details - K000171
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K000171
Device Name
Neurological Stereotaxic Instrument
Applicant
CBYON, INC.
2275 E. BAYSHORE RD.
SUITE 101
PALO ALTO, CA 94303 US
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Contact
RORY RANDALL
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
HAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/20/2000
Decision Date
03/13/2000
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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