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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 K090044
Device Name PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C
Applicant
Oncolog Medical QA AB
Vallvagen 4b
Uppsala,  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 Received01/07/2009
Decision Date 01/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized
No
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