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FDA 510(k) Application Details - K003347
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K003347
Device Name
Neurological Stereotaxic Instrument
Applicant
KINAMED, INC.
9229 CRANFORD DR.
POTOMAC, MD 20854 US
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Contact
JOEL SLOMOFF
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
10/25/2000
Decision Date
02/23/2001
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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