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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K895524
Device Name HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.
Applicant
Theramed, Inc.
P.O. Box 5886
Ft. Lauderdale,  FL  33310
Applicant Contact CHARLES HOKANSON
Correspondent
Theramed, Inc.
P.O. Box 5886
Ft. Lauderdale,  FL  33310
Correspondent Contact CHARLES HOKANSON
Regulation Number882.5550
Classification Product Code
JXG  
Date Received09/12/1989
Decision Date 04/10/1990
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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