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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, assisted reproduction
510(k) Number K173431
Device Name Towako Transmyometrial Embryo Transfer Set
Applicant
William A. Cook Australia PTY LTD
95 Brandl Street
Eight Mile Plains,  AU 4113
Applicant Contact Gordana Pozvek
Correspondent
William A. Cook Australia PTY LTD
95 Brandl Street
Eight Mile Plains,  AU 4113
Correspondent Contact Gordana Pozvek
Regulation Number884.6110
Classification Product Code
MQF  
Date Received11/02/2017
Decision Date 05/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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