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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 K120877
Device Name MICROMANIPULATOR SET
Applicant
Narishige Co., Ltd.
27-9 Minamikarasuyama 4-Chome
Setagaya-Ku, Tokyo,  JP 157-0062
Applicant Contact MITSUKO YONEYAMA
Correspondent
Narishige Co., Ltd.
27-9 Minamikarasuyama 4-Chome
Setagaya-Ku, Tokyo,  JP 157-0062
Correspondent Contact MITSUKO YONEYAMA
Regulation Number884.6150
Classification Product Code
MQJ  
Date Received03/23/2012
Decision Date 06/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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