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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 K152782
Device Name SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT
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 Received09/25/2015
Decision Date 12/21/2015
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
Predetermined Change
Control Plan Authorized		 No
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