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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
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