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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Shunt System Implantation
510(k) Number K962761
Device Name REIGEL TUNNELING DEVICE
Applicant
Cook, Inc.
P.O.Box 489
Bloomington,  IN  47402
Applicant Contact APRIL LAVENDER
Correspondent
Cook, Inc.
P.O.Box 489
Bloomington,  IN  47402
Correspondent Contact APRIL LAVENDER
Regulation Number882.4545
Classification Product Code
GYK  
Date Received07/16/1996
Decision Date 10/11/1996
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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