MN-4 COARSE MANIPULATOR

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 Mn-4 Coarse Manipulator.

Pre-market Notification Details

Device IDK010298
510k NumberK010298
Device Name:MN-4 COARSE MANIPULATOR
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 Received2001-01-31
Decision Date2001-03-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04589818020043 K010298 000

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