DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER

Catheter, Retention Type, Balloon

THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP

The following data is part of a premarket notification filed by The Kendall Company Div. Of Tyco Healthcare Group with the FDA for Dover Silver Hydrogel Coated Silicone Foley Catheter.

Pre-market Notification Details

Device IDK024010
510k NumberK024010
Device Name:DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
ClassificationCatheter, Retention Type, Balloon
Applicant THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP 15 HAMPSHIRE ST. Mansfield,  MA  02048
ContactDavid A Olson
CorrespondentDavid A Olson
THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP 15 HAMPSHIRE ST. Mansfield,  MA  02048
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-04
Decision Date2003-06-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521723372 K024010 000
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10884521723283 K024010 000
30884521026517 K024010 000

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