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510(k) K171625

Single Lumen Ovum Aspiration Needles by Willian A. Cook Australia Pty, Ltd. — Product Code MQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2018
Date Received
June 2, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6100
Review Panel
OB
Submission Type

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