Kitazato OPU Needles

Needle, Assisted Reproduction

Kitazato Corporation

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

Pre-market Notification Details

Device IDK162881
510k NumberK162881
Device Name:Kitazato OPU Needles
ClassificationNeedle, Assisted Reproduction
Applicant Kitazato Corporation 1-1-8 Shibadaimon, Minato-ku Tokyo,  JP 105-0012
ContactMari Yazaki
CorrespondentAudrey Swearingen
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1 Suite 300 Austin,  TX  78746
Product CodeMQE  
CFR Regulation Number884.6100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-14
Decision Date2017-07-11
Summary:summary

NIH GUDID Devices

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