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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 K903844
Device Name OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING
Applicant
CORDIS CORP.
P.O. BOX 025700
MIAMI,  FL  33102
Applicant Contact MARVIN L SUSSMAN
Correspondent
CORDIS CORP.
P.O. BOX 025700
MIAMI,  FL  33102
Correspondent Contact MARVIN L SUSSMAN
Regulation Number882.5550
Classification Product Code
JXG  
Date Received08/21/1990
Decision Date 12/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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