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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Charged-Particle, Medical
510(k) Number K983660
Device Name EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)
Applicant
Brainlab, Inc.
3100 Hansen Way
Bldg. 4a, Mailstop E233
Palo Alto,  CA  94304
Applicant Contact ERIC LINDQUIST
Correspondent
Brainlab, Inc.
3100 Hansen Way
Bldg. 4a, Mailstop E233
Palo Alto,  CA  94304
Correspondent Contact ERIC LINDQUIST
Regulation Number892.5050
Classification Product Code
LHN  
Date Received10/19/1998
Decision Date 07/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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