ZUTRON COLONOSCOPE STIFFENING DEVICE

Colonoscope And Accessories, Flexible/rigid

ZUTRON MEDICAL

The following data is part of a premarket notification filed by Zutron Medical with the FDA for Zutron Colonoscope Stiffening Device.

Pre-market Notification Details

Device IDK051068
510k NumberK051068
Device Name:ZUTRON COLONOSCOPE STIFFENING DEVICE
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant ZUTRON MEDICAL 9816 PFLUMM RD Lenexa,  KS  66215
ContactJordan Hartong
CorrespondentJordan Hartong
ZUTRON MEDICAL 9816 PFLUMM RD Lenexa,  KS  66215
Product CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-26
Decision Date2005-07-11
Summary:summary

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