FDA 510(k) Application Details - K090348

Device Classification Name Shunt, Central Nervous System And Components

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510(K) Number K090348
Device Name Shunt, Central Nervous System And Components
Applicant Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
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Contact SHARON MCDERMOTT
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Regulation Number 882.5550

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Classification Product Code JXG
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Date Received 02/11/2009
Decision Date 03/04/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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