MOTOR-DRIVE MANIPULATOR MM-89

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 Motor-drive Manipulator Mm-89.

Pre-market Notification Details

Device IDK002291
510k NumberK002291
Device Name:MOTOR-DRIVE MANIPULATOR MM-89
ClassificationMicromanipulators And Microinjectors, Assisted Reproduction
Applicant NARISHIGE CO., LTD. 27-9 MINAMIKARASUYAMA 4-CHOME Setagay-ku, Tokyo,  JP 157-0062
ContactMitsuko Yoneyama
CorrespondentMitsuko Yoneyama
NARISHIGE CO., LTD. 27-9 MINAMIKARASUYAMA 4-CHOME Setagay-ku, Tokyo,  JP 157-0062
Product CodeMQJ  
CFR Regulation Number884.6150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-27
Decision Date2000-09-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04589818020036 K002291 000

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