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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 K961120
Device Name MARKER SYSTEM FOR STEREOTAXIC NAVIGATION
Applicant
Howmedica Leibinger, Inc.
14540 Beltwood Pkwy. E.
Dallas,  TX  75244
Applicant Contact ANDREW B ROGERS
Correspondent
Howmedica Leibinger, Inc.
14540 Beltwood Pkwy. E.
Dallas,  TX  75244
Correspondent Contact ANDREW B ROGERS
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/21/1996
Decision Date 05/10/1996
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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