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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Couch, Radiation Therapy, Powered
510(k) Number K033316
Device Name TABLE TILT DEVICE
Applicant
Brainlab AG
Ammerthalstrasse 8
Heimstetten,  DE 85551
Applicant Contact RAINER BIRKENBACH
Correspondent
Brainlab AG
Ammerthalstrasse 8
Heimstetten,  DE 85551
Correspondent Contact RAINER BIRKENBACH
Regulation Number892.5770
Classification Product Code
JAI  
Date Received10/15/2003
Decision Date 05/14/2004
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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