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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Charged-Particle, Medical
510(k) Number K082416
Device Name IBA PROTON THERAPY SYSTEM- PROTEUS 235
Applicant
Ion Beam Applications S.A.
1500 Market St.
Centre Square W., 38th Floor
Philadelphia,  PA  19102
Applicant Contact JOHN REISS
Correspondent
Ion Beam Applications S.A.
1500 Market St.
Centre Square W., 38th Floor
Philadelphia,  PA  19102
Correspondent Contact JOHN REISS
Regulation Number892.5050
Classification Product Code
LHN  
Date Received08/21/2008
Decision Date 12/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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