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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 K963256
Device Name NEUROMATE STEREOTACTIC SYSTEM
Applicant
Integrated Surgical Systems, S.A.
70 Walnut St.
Wellesley,  MA  02181
Applicant Contact JEAN-LUC BOULNOIS, PH.D.
Correspondent
Integrated Surgical Systems, S.A.
70 Walnut St.
Wellesley,  MA  02181
Correspondent Contact JEAN-LUC BOULNOIS, PH.D.
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/19/1996
Decision Date 05/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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