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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 K024010
Device Name DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
Applicant
The Kendall Company Div. of Tyco Healthcare Group
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact DAVID A OLSON
Correspondent
The Kendall Company Div. of Tyco Healthcare Group
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact DAVID A OLSON
Regulation Number876.5130
Classification Product Code
EZL  
Subsequent Product Code
KOD  
Date Received12/04/2002
Decision Date 06/11/2003
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 No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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