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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 K153478
Device Name Sydney IVF Gamete Buffer
Applicant
William A. Cook Australia Pty. , Ltd.
95 Brandl St.
Eight Mile Plains,  AU 4113
Applicant Contact Gordana Pozvek
Correspondent
William A. Cook Australia Pty. , Ltd.
95 Brandl St.
Eight Mile Plains,  AU 4113
Correspondent Contact Gordana Pozvek
Regulation Number884.6180
Classification Product Code
MQL  
Date Received12/02/2015
Decision Date 08/15/2016
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 Yes
Predetermined Change
Control Plan Authorized		 No
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