FDA 510(k) Application Details - K011736

Device Classification Name Methyl Methacrylate For Cranioplasty

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510(K) Number K011736
Device Name Methyl Methacrylate For Cranioplasty
Applicant DOCTOR'S RESEARCH GROUP, INC.
143 WOLCOTT RD.
WOLCOTT, CT 06716 US
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Contact RICHARD DESLAURIES
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Regulation Number 882.5300

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Classification Product Code GXP
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Date Received 06/05/2001
Decision Date 01/30/2002
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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