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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 K060737
Device Name SINMED POSITIONING DEVICES
Applicant
Sinmed BV
6,Pasteurstraat
Reeuwijk,  NL 2811 DX
Applicant Contact CAROLINE DE KEIJZER
Correspondent
Kema Quality B.V.
4377 County Line Rd.
Chalfont,  PA  18914
Correspondent Contact J.A. VAN VUGT
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/20/2006
Decision Date 03/31/2006
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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