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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 K113712
Device Name IM-11 PNEUMATIC MICROINJECTOR
Original Applicant
NARISHIGE CO., LTD.
27-9 minamikarasuyama 4-chome
setagaya-ku, tokyo,  JA 157-0062
Original Contact mitsuko yoneyama
Regulation Number884.6150
Classification Product Code
MQJ  
Date Received12/19/2011
Decision Date 03/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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