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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 K921936
Device Name CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR
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 Received04/24/1992
Decision Date 10/30/1992
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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