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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Micromanipulators And Microinjectors, Assisted Reproduction
510(k) Number K002293
Device Name 3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE
Applicant
NARISHIGE CO., LTD.
27-9 MINAMIKARASUYAMA 4-CHOME
SETAGAY-KU, TOKYO,  JP 157-0062
Applicant Contact MITSUKO YONEYAMA
Correspondent
NARISHIGE CO., LTD.
27-9 MINAMIKARASUYAMA 4-CHOME
SETAGAY-KU, TOKYO,  JP 157-0062
Correspondent Contact MITSUKO YONEYAMA
Regulation Number884.6150
Classification Product Code
MQJ  
Date Received07/27/2000
Decision Date 09/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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