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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 K120676
Device Name S-250 PROTON BEAM RADIATION THERAPY SYSTEM
Applicant
MEVION MEDICAL SYSTEMS
300 FOSTER ST
LITTLETON,  MA  01460
Applicant Contact THOMAS H FARIS
Correspondent
MEVION MEDICAL SYSTEMS
300 FOSTER ST
LITTLETON,  MA  01460
Correspondent Contact THOMAS H FARIS
Regulation Number892.5050
Classification Product Code
LHN  
Date Received03/05/2012
Decision Date 06/04/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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