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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Lesion, Radiofrequency
510(k) Number K896450
Device Name NEURO N 50 LESION GENERATOR
Applicant
Leibinger & Fischer , Ltd.
4500 Trammell Crow Center
2001 Ross Ave.
Dallas,  TX  75201
Applicant Contact PAUL STEWART
Correspondent
Leibinger & Fischer , Ltd.
4500 Trammell Crow Center
2001 Ross Ave.
Dallas,  TX  75201
Correspondent Contact PAUL STEWART
Regulation Number882.4400
Classification Product Code
GXD  
Date Received11/09/1989
Decision Date 03/19/1991
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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