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FDA 510(k) Application Details - K990683
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K990683
Device Name
Neurological Stereotaxic Instrument
Applicant
AXON INSTRUMENTS, INC.
1101 CHESS DR.
FOSTER CITY, CA 94404-1102 US
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Contact
ANDREW L BLATZ
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
03/03/1999
Decision Date
11/03/1999
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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