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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 K944595
Device Name CORDIS HORIZONTAL-VERICAL VALVE SYSTEM
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact MARVIN L SUSSMAN
Correspondent
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact MARVIN L SUSSMAN
Regulation Number882.5550
Classification Product Code
JXG  
Date Received09/19/1994
Decision Date 10/19/1995
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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