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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 K932273
Device Name CORDIS TUNNELER
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 Number882.4545
Classification Product Code
GYK  
Subsequent Product Code
JXG  
Date Received05/13/1993
Decision Date 08/23/1993
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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