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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 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 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
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