FDA 510(k) Application Details - K023575

Device Classification Name Methyl Methacrylate For Cranioplasty

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510(K) Number K023575
Device Name Methyl Methacrylate For Cranioplasty
Applicant IMMEDICA, INC.
719 A STREET, NE
WASHINGTON, DC 20002 US
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Contact RUSSELL PAGANO
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Regulation Number 882.5300

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Classification Product Code GXP
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Date Received 10/24/2002
Decision Date 01/22/2003
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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