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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K990500
Device Name KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
Applicant
THE KENDAL CO.
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048 -1108
Applicant Contact PAUL W EVANS
Correspondent
THE KENDAL CO.
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048 -1108
Correspondent Contact PAUL W EVANS
Regulation Number876.5130
Classification Product Code
EZL  
Date Received02/17/1999
Decision Date 09/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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