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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
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