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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 K042709
Device Name DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
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 Received09/30/2004
Decision Date 01/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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