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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 K003142
Device Name MICROMANIPULATOR
Applicant
RESEARCH INSTRUMENTS LTD.
KERNICK RD.
PENRYN, CORWALL,  GB TR 10 9DQ
Applicant Contact BEN MURDOCK
Correspondent
RESEARCH INSTRUMENTS LTD.
KERNICK RD.
PENRYN, CORWALL,  GB TR 10 9DQ
Correspondent Contact BEN MURDOCK
Regulation Number884.6150
Classification Product Code
MQJ  
Date Received10/10/2000
Decision Date 11/22/2000
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
Recalls CDRH Recalls
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