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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 K946033
Device Name LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE
Applicant
Leibinger GmbH
C/O Hogan & Hartson
555 Thirteenth St., NW
Washington,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Leibinger GmbH
C/O Hogan & Hartson
555 Thirteenth St., NW
Washington,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/09/1994
Decision Date 09/01/1995
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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