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FDA 510(k) Application Details - K002063
Device Classification Name
Accessory,Barium Sulfate,Methyl Methacrylate For Cranioplasty
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510(K) Number
K002063
Device Name
Accessory,Barium Sulfate,Methyl Methacrylate For Cranioplasty
Applicant
BRYAN CORP.
FOUR PLYMPTON ST.
WOBURN, MA 01801 US
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Contact
ROSE S LOGSDON
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Regulation Number
882.5300
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Classification Product Code
MYU
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More FDA Info for this Product Code
Date Received
07/07/2000
Decision Date
08/10/2000
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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