Cryotop Vitrification Kit And Cryotop Thawing Kit

Media, Reproductive

KITAZATO BIOPHARMA CO., LTD.

The following data is part of a premarket notification filed by Kitazato Biopharma Co., Ltd. with the FDA for Cryotop Vitrification Kit And Cryotop Thawing Kit.

Pre-market Notification Details

Device IDK160864
510k NumberK160864
Device Name:Cryotop Vitrification Kit And Cryotop Thawing Kit
ClassificationMedia, Reproductive
Applicant KITAZATO BIOPHARMA CO., LTD. 81 NAKIJIMA Fuji,  JP 416-0907
ContactFutoshi Inoue
CorrespondentRichard Vincins
EMERGO GLOBAL CONSULTING, LLC 816 CONGRESS AVENUE, SUITE 1400 Austin,  TX  78701
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2016-03-29
Decision Date2016-10-07
Summary:summary

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