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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K012514
Device Name DIGIPAN / DPI
Applicant
TROPHY RADIOLOGIE
4 RUE F. PELLOUTIER
CROISSY-BEAUBOURG
MARNE LA VALLEE CEDEX 2,  FR 77437
Applicant Contact MARIE-PIERRE LABAT-CAMY
Correspondent
TROPHY RADIOLOGIE
4 RUE F. PELLOUTIER
CROISSY-BEAUBOURG
MARNE LA VALLEE CEDEX 2,  FR 77437
Correspondent Contact MARIE-PIERRE LABAT-CAMY
Regulation Number872.1800
Classification Product Code
MUH  
Date Received08/06/2001
Decision Date 12/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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