Cytosponge Cell Collection Device

Esophagoscope (flexible Or Rigid)

Covidien LLC

The following data is part of a premarket notification filed by Covidien Llc with the FDA for Cytosponge Cell Collection Device.

Pre-market Notification Details

Device IDK152794
510k NumberK152794
Device Name:Cytosponge Cell Collection Device
ClassificationEsophagoscope (flexible Or Rigid)
Applicant Covidien LLC 15 Hampshire Street Mansfield,  MA  02040 8
ContactClare Santulli
CorrespondentSaket Bhatt
Covidien LLC 15 Hampshire Street Mansfield,  MA  02040 -0008
Product CodeEOX  
CFR Regulation Number874.4710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-28
Decision Date2016-04-12
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.