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510(k) K152904

SYDNEY IVF EMBRYO BIOPSY MEDIUM by William A. Cook Australia Pty. , Ltd. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2015
Date Received
October 1, 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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