DOVER RED RUBBER ROBINSON CATHETER

Catheter, Urological

TYCO HEALTHCARE

The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Dover Red Rubber Robinson Catheter.

Pre-market Notification Details

Device IDK041243
510k NumberK041243
Device Name:DOVER RED RUBBER ROBINSON CATHETER
ClassificationCatheter, Urological
Applicant TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield,  MA  02048
ContactWei Zhao
CorrespondentWei Zhao
TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield,  MA  02048
Product CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-11
Decision Date2004-07-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30884521030484 K041243 000
20884521030470 K041243 000
30884521030460 K041243 000
30884521019830 K041243 000
30884521019823 K041243 000

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