Kitazato ET Catheters

Catheter, Assisted Reproduction

Kitazato Corporation

The following data is part of a premarket notification filed by Kitazato Corporation with the FDA for Kitazato Et Catheters.

Pre-market Notification Details

Device IDK192540
510k NumberK192540
Device Name:Kitazato ET Catheters
ClassificationCatheter, Assisted Reproduction
Applicant Kitazato Corporation Shibakoen Building, 1-1-8 Shibadaimon, Minato-ku Tokyo,  JP 105-0012
ContactFutoshi Inoue
CorrespondentAudrey Swearingen
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Ste 300 Austin,  TX  78746
Product CodeMQF  
CFR Regulation Number884.6110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-16
Decision Date2020-05-01

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