FDA 510(k) Application Details - K955832

Device Classification Name Shunt, Central Nervous System And Components

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510(K) Number K955832
Device Name Shunt, Central Nervous System And Components
Applicant CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES, FL 33014 US
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Contact STEPHEN M ENOS
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Regulation Number 882.5550

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Classification Product Code JXG
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Date Received 12/26/1995
Decision Date 03/25/1996
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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