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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 K142207
Device Name TransferMan 4m Micromanipulator
Applicant
Eppendorf AG
Barkhansenweg 1
Hamburg,  DE 22339
Applicant Contact CORNELIA HILDEBRANDT
Correspondent
Aptiv Solutions
62 Forest St., Suite 300
Marlborough,  MA  01752
Correspondent Contact JO ANNE BRONIKOWSKI
Regulation Number884.6150
Classification Product Code
MQJ  
Date Received08/11/2014
Decision Date 01/23/2015
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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