FDA 510(k) Application Details - K962337

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

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510(K) Number K962337
Device Name Unit, X-Ray, Extraoral With Timer
Applicant TROPHY RADIOLOGIE
106, RUE DE LA JARRY
B.P. 20
VINCENNES, CEDEX (PARIS) 94307 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 06/17/1996
Decision Date 07/25/1996
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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