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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, urological
510(k) Number K933400
Device Name KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR
Applicant
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact PAUL W EVANS
Correspondent
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact PAUL W EVANS
Regulation Number876.5130
Classification Product Code
KOD  
Date Received07/12/1993
Decision Date 11/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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