FDA 510(k) Application Details - K991912

Device Classification Name Unit, X-Ray, Extraoral With Timer

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510(K) Number K991912
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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Contact MARIR-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 06/07/1999
Decision Date 06/22/1999
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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