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510(k) K152682

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit by Willian A. Cook Australia Pty, Ltd. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2016
Date Received
September 18, 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

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