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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 K920879
Device Name BRAINSCAN RADIOSURGERY MODULE
Original Applicant
BRAINLAB
wittelsbacherstr. 8
d-8011 poing b. munchen
west germany,  GM
Original Contact stefan vilsmeier
Regulation Number892.5050
Classification Product Code
IYE  
Date Received02/26/1992
Decision Date 12/29/1992
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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