PBS(-), Phosphate Buffered Saline

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 Pbs(-), Phosphate Buffered Saline.

Pre-market Notification Details

Device IDK160863
510k NumberK160863
Device Name:PBS(-), Phosphate Buffered Saline
ClassificationMedia, Reproductive
Applicant KITAZATO BIOPHARMA CO., LTD. 81 NAKIJIMA Fuji,  JP 416-0907
ContactFutoshi Inoue
CorrespondentDiane Sudduth
EMERGO GLOBAL CONSULTING, LLC 816 CONGRESS AVENUE, 1400 Austin,  TX  78701
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-29
Decision Date2016-07-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04573316381577 K160863 000
04573316381560 K160863 000

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