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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Synchrotron, Medical
510(k) Number K872369
Device Name LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEM
Applicant
Loma Linda University Medical Center
11234 Anderson St.
P.O. Box 2000
Loma Linda,  CA  92354
Applicant Contact J ANDERSON
Correspondent
Loma Linda University Medical Center
11234 Anderson St.
P.O. Box 2000
Loma Linda,  CA  92354
Correspondent Contact J ANDERSON
Regulation Number892.5050
Classification Product Code
IWM  
Date Received06/19/1987
Decision Date 02/22/1988
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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