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FDA 510(k) Application Details - K060292
Device Classification Name
Unit, X-Ray, Extraoral With Timer
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510(K) Number
K060292
Device Name
Unit, X-Ray, Extraoral With Timer
Applicant
KODAK-TROPHY
4 RUE FERDINAND PELLOUTIER
CROISSY-BEAUBOURG
MARNE LA VALLEE CEDEX 2 77 437 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
02/06/2006
Decision Date
03/03/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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