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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 K954861
Device Name BRAINLAB CT/X-RAY LOCALIZER
Applicant
Brainlab Med. Computersysteme GmbH
Gruber Strabe 46c
85586 Poing/Munchen,  DE 85586
Applicant Contact MICHAEL BERTRAM
Correspondent
Brainlab Med. Computersysteme GmbH
Gruber Strabe 46c
85586 Poing/Munchen,  DE 85586
Correspondent Contact MICHAEL BERTRAM
Regulation Number892.5050
Classification Product Code
IYE  
Date Received10/23/1995
Decision Date 08/05/1996
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
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