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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Contact MARIE-PIERRE LABAT-CAMY
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Regulation Number 872.1800

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Classification Product Code EHD
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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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