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FDA 510(k) Application Details - K093478
Device Classification Name
System,X-Ray,Extraoral Source,Digital
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510(K) Number
K093478
Device Name
System,X-Ray,Extraoral Source,Digital
Applicant
TROPHY
4 RUE F. PELLOUTIER
CROISSY-BEAUBOURG 77435 FR
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Contact
MARIE-PIERRE LABAT-CAMY
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Regulation Number
872.1800
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Classification Product Code
MUH
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Date Received
11/09/2009
Decision Date
04/26/2010
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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