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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, planning, radiation therapy treatment
510(k) Number K002509
Device Name NOVALIS (SHAPED BEAM SURGERY SYSTEM)
Applicant
BRAINLAB AG
AMMERTHALSTRASSE 8
HEIMSTETTEN,  DE 85551
Applicant Contact STEFAN VILSMEIER
Correspondent
BRAINLAB AG
AMMERTHALSTRASSE 8
HEIMSTETTEN,  DE 85551
Correspondent Contact STEFAN VILSMEIER
Regulation Number892.5050
Classification Product Code
MUJ  
Subsequent Product Code
IYE  
Date Received08/15/2000
Decision Date 11/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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