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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K952390
Device Name BRAINLAB STEROTATIC HEADRING
Applicant
BRAINLAB MED. COMPUTERSYSTEME GMBH
GRUBER STRABE 46C
85586 POING/MUNCHEN,  DE 85586
Applicant Contact STEFAN VILSMEIER
Correspondent
BRAINLAB MED. COMPUTERSYSTEME GMBH
GRUBER STRABE 46C
85586 POING/MUNCHEN,  DE 85586
Correspondent Contact STEFAN VILSMEIER
Regulation Number882.4560
Classification Product Code
HAW  
Date Received05/22/1995
Decision Date 02/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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