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510(k) K153290

Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium by William A. Cook Australia Pty. , Ltd. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2016
Date Received
November 13, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type

Other clearances by William A. Cook Australia Pty. , Ltd.

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  • K160814 — Sydney IVF Sperm Cryopreservation Buffer (April 22, 2016)
  • K151367 — Sydney IVF Hyaluronidase (January 27, 2016)
  • K152782 — SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT (December 21, 2015)
  • K152904 — SYDNEY IVF EMBRYO BIOPSY MEDIUM (December 3, 2015)

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