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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 K072374
Device Name COMPASS
Applicant
Scanditronix Wellhofer GmbH
Bahnofstrasse 5
Schwarzenbruck,  DE 90592
Applicant Contact MARTIN AROLD
Correspondent
Scanditronix Wellhofer GmbH
Bahnofstrasse 5
Schwarzenbruck,  DE 90592
Correspondent Contact MARTIN AROLD
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/23/2007
Decision Date 12/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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