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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