FDA 510(k) Application Details - K041518

Device Classification Name Dura Substitute

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510(K) Number K041518
Device Name Dura Substitute
Applicant Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
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Contact ELIZABETH DOLAN
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Regulation Number 882.5910

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Classification Product Code GXQ
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Date Received 06/07/2004
Decision Date 06/22/2004
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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