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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 K151207
Device Name Proton Immobilization Solution
Applicant
Orfit Industries NV
Vosveld 9a
Wijnegem,  BE B-2110
Applicant Contact EDDY MARIVOET
Correspondent
P/L Biomedical
10882 Stonington Ave.
Fort Myers,  FL  33913
Correspondent Contact LEE LEICHTER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/06/2015
Decision Date 07/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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