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FDA 510(k) Application Details - K033690
Device Classification Name
Unit, X-Ray, Extraoral With Timer
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510(K) Number
K033690
Device Name
Unit, X-Ray, Extraoral With Timer
Applicant
TROPHY RADIOLOGIE
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
EHD
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More FDA Info for this Product Code
Date Received
11/24/2003
Decision Date
02/20/2004
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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