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FDA 510(k) Application Details - K991081
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K991081
Device Name
Neurological Stereotaxic Instrument
Applicant
INTEGRATED SURGICAL SYSTEMS, INC.
1850 RESEARCH PARK DR.
DAVIS, CA 95616 US
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Contact
R.D. HIBBERT
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
03/31/1999
Decision Date
06/25/1999
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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