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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 K991081
Device Name FRAMELESS NEUROMATE
Applicant
Integrated Surgical Systems, Inc.
1850 Research Park Dr.
Davis,  CA  95616
Applicant Contact R.D. HIBBERT
Correspondent
Integrated Surgical Systems, Inc.
1850 Research Park Dr.
Davis,  CA  95616
Correspondent Contact R.D. HIBBERT
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/31/1999
Decision Date 06/25/1999
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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