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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 K092939
Device Name PATLOG 2.0
Applicant
ONCOLOG MEDICAL QA AB
VALLVAGEN 4B
UPPSALA,  SE SE 756-51
Applicant Contact JAN TORNQVIST
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/24/2009
Decision Date 10/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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