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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K004023
Device Name INTRA OPERATIVE RADIATION THERAPY
Applicant
Arplay Medical S.A.
1, Route De Citeaux
Izeure, Cote D'Or,  FR 21110
Applicant Contact RICHARD BORGI
Correspondent
Arplay Medical S.A.
1, Route De Citeaux
Izeure, Cote D'Or,  FR 21110
Correspondent Contact RICHARD BORGI
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/27/2000
Decision Date 09/21/2001
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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