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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 K071049
Device Name DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
Applicant
TYCO HEALTHCARE
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact WEI ZHAO
Correspondent
TYCO HEALTHCARE
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact WEI ZHAO
Regulation Number876.5130
Classification Product Code
EZL  
Date Received04/13/2007
Decision Date 10/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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