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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, assisted reproduction
510(k) Number K171625
Device Name Single Lumen Ovum Aspiration Needles
Applicant
Willian A. Cook Australia Pty Ltd
95 Brandl Street
Eight Mile Plains,  AU 4113
Applicant Contact Gordana Pozvek
Correspondent
Willian A. Cook Australia Pty Ltd
95 Brandl Street
Eight Mile Plains,  AU 4113
Correspondent Contact Gordana Pozvek
Regulation Number884.6100
Classification Product Code
MQE  
Date Received06/02/2017
Decision Date 01/12/2018
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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