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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 K092018
Device Name OMNIPRO INCLINE
Applicant
IBA DOSIMETRY GMBH
3150 STAGE POST DR
SUITE 110
BARTLETT,  TN  38133
Applicant Contact CHUCK LINDLEY
Correspondent
IBA DOSIMETRY GMBH
3150 STAGE POST DR
SUITE 110
BARTLETT,  TN  38133
Correspondent Contact CHUCK LINDLEY
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/06/2009
Decision Date 09/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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