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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K991455
Device Name ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,
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
EHD  
Date Received04/26/1999
Decision Date 06/25/1999
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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