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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K881323
Device Name CURIETRON 192 LOW DOSE RATE
Applicant
Compagnie Oris Industrie, S.A.
Boite Postale 6
F 91192 Gif-Sur-Yvette Cedex
France,  FR
Applicant Contact MICHAEL D GARRETT
Correspondent
Compagnie Oris Industrie, S.A.
Boite Postale 6
F 91192 Gif-Sur-Yvette Cedex
France,  FR
Correspondent Contact MICHAEL D GARRETT
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received03/28/1988
Decision Date 01/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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