FDA 510(k) Application Details - K990290

Device Classification Name Methyl Methacrylate For Cranioplasty

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510(K) Number K990290
Device Name Methyl Methacrylate For Cranioplasty
Applicant BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW, IN 46581-0587 US
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Contact MICHELLE L MCKINLEY
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Regulation Number 882.5300

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Classification Product Code GXP
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Date Received 01/29/1999
Decision Date 11/18/1999
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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