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FDA 510(k) Application Details - K073435
Device Classification Name
System,X-Ray,Extraoral Source,Digital
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510(K) Number
K073435
Device Name
System,X-Ray,Extraoral Source,Digital
Applicant
TROPHY
4 RUE F. PELLOUTIER CROISSY
BEAUBOURG
MARNE LA VALLEE CEDEX 2 77437 FR
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MARIE-PIERRE LABAT-CAMY
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Regulation Number
872.1800
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Classification Product Code
MUH
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More FDA Info for this Product Code
Date Received
12/06/2007
Decision Date
02/11/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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