FDA 510(k) Applications Submitted by Gordana Pozvek

FDA 510(k) Number Submission Date Device Name Applicant
K170257 01/27/2017 Sydney IVF Culture Oil William A. Cook Australia Pty Ltd
K160753 03/18/2016 COOK Vacuum Pump WILLIAM A. COOK AUSTRALIA PTY LTD
K160814 03/24/2016 Sydney IVF Sperm Cryopreservation Buffer WILLIAM A. COOK AUSTRALIA PTY LTD
K151367 05/21/2015 Sydney IVF Hyaluronidase WILLIAM A. COOK AUSTRALIA PTY LTD
K171611 06/01/2017 Double Lumen Ovum Aspiration Needles William A. Cook Australia Pty Ltd
K171625 06/02/2017 Single Lumen Ovum Aspiration Needles Willian A. Cook Australia Pty Ltd
K152440 08/27/2015 Sydney IVF PVP WILLAM A. COOK AUSTRALIA PTY LTD
K152682 09/18/2015 Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit WILLIAN A. COOK AUSTRALIA PTY LTD
K152717 09/21/2015 Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit WILLIAM A. COOK AUSTRALIA PTY, LTD.
K152782 09/25/2015 SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT WILLIAM A. COOK AUSTRALIA PTY LTD
K152904 10/01/2015 SYDNEY IVF EMBRYO BIOPSY MEDIUM WILLIAM A. COOK AUSTRALIA PTY, LTD.
K173431 11/02/2017 Towako Transmyometrial Embryo Transfer Set William A. Cook Australia PTY LTD
K153290 11/13/2015 Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium WILLIAM A. COOK AUSTRALIA PTY LTD
K153478 12/02/2015 Sydney IVF Gamete Buffer WILLIAM A. COOK AUSTRALIA PTY LTD
K143724 12/29/2014 COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit WILLIAM A. COOK AUSTRALIA PTY, LTD.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact