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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 K874693
Device Name OBT STEREOTACTIC SYSTEM
Applicant
Tipal Instruments , Ltd.
128 Ronald Dr.
Montreal, Quebec,  CA H4X 1M8
Applicant Contact KARIN DERY
Correspondent
Tipal Instruments , Ltd.
128 Ronald Dr.
Montreal, Quebec,  CA H4X 1M8
Correspondent Contact KARIN DERY
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/05/1987
Decision Date 03/11/1988
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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