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FDA 510(k) Application Details - K953568
Device Classification Name
Neurological Stereotaxic Instrument
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510(K) Number
K953568
Device Name
Neurological Stereotaxic Instrument
Applicant
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
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SIGI CARON
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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
07/31/1995
Decision Date
02/29/1996
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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