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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name media, reproductive
510(k) Number K170257
Device Name Sydney IVF Culture Oil
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 Number884.6180
Classification Product Code
MQL  
Date Received01/27/2017
Decision Date 02/24/2017
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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