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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 K151946
Device Name Thermofit
Applicant
Orfit Industries
Vosveld 9a, B-2110 Wijnegem
Wijnegem, Belgium,  BE
Applicant Contact EDDY MAROVOET
Correspondent
P/L Biomedical
10882 Stonington Ave.
Fort Myers,  FL  33913
Correspondent Contact LEE LEICHTER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/14/2015
Decision Date 11/09/2015
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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