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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 K143724
Device Name COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit
Applicant
WILLIAM A. COOK AUSTRALIA PTY, LTD.
95 BRANDL ST
EIGHT MILE PLAINS
BRISBANE,  AU QLD 4113
Applicant Contact Gordana Pozvek
Correspondent
WILLIAM A. COOK AUSTRALIA PTY, LTD.
95 BRANDL ST
EIGHT MILE PLAINS
BRISBANE,  AU QLD 4113
Correspondent Contact Gordana Pozvek
Regulation Number884.6180
Classification Product Code
MQL  
Date Received12/29/2014
Decision Date 08/27/2015
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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