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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 K970586
Device Name BRAINLAB MICRO MULTI-LEAF COLLIMATOR
Applicant
Brainlab Med. Computersysteme GmbH
Ammerthalstrabe 8
85551 Heimstetten,  DE
Applicant Contact STEFAN VILSMEIER
Correspondent
Brainlab Med. Computersysteme GmbH
Ammerthalstrabe 8
85551 Heimstetten,  DE
Correspondent Contact STEFAN VILSMEIER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received02/14/1997
Decision Date 05/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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