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FDA 510(k) Application Details - K031732
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K031732
Device Name
Neurological Stereotaxic Instrument
Applicant
EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY, NJ 07054 US
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Contact
JON CAPAROTTA
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
06/04/2003
Decision Date
10/15/2003
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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