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510(k) K153478

Sydney IVF Gamete Buffer by William A. Cook Australia Pty. , Ltd. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2016
Date Received
December 2, 2015
Clearance Type
Traditional
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

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  • 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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