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FDA 510(k) Application Details - K001642
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K001642
Device Name
Neurological Stereotaxic Instrument
Applicant
SURGICAL INSIGHTS, INC.
1840 OAK AVE.
EVANSTON, IL 60201 US
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Contact
JON T LEA
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
05/30/2000
Decision Date
09/12/2000
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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