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510(k) K151018

Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette by Cook Incorporated — Product Code MQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2016
Date Received
April 16, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microtools, Assisted Reproduction (Pipettes)
Device Class
Class II
Regulation Number
884.6130
Review Panel
OB
Submission Type

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