IM-11 PNEUMATIC MICROINJECTOR

Micromanipulators And Microinjectors, Assisted Reproduction

NARISHIGE CO., LTD.

The following data is part of a premarket notification filed by Narishige Co., Ltd. with the FDA for Im-11 Pneumatic Microinjector.

Pre-market Notification Details

Device IDK113712
510k NumberK113712
Device Name:IM-11 PNEUMATIC MICROINJECTOR
ClassificationMicromanipulators And Microinjectors, Assisted Reproduction
Applicant NARISHIGE CO., LTD. 27-9 MINAMIKARASUYAMA 4-CHOME Setagaya-ku, Tokyo,  JP 157-0062
ContactMitsuko Yoneyama
CorrespondentMitsuko Yoneyama
NARISHIGE CO., LTD. 27-9 MINAMIKARASUYAMA 4-CHOME Setagaya-ku, Tokyo,  JP 157-0062
Product CodeMQJ  
CFR Regulation Number884.6150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-19
Decision Date2012-03-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04589818020050 K113712 000

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