Home / 510(k) Clearances / K191015

510(k) K191015

Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) by Cook Incorporated — Product Code MQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2019
Date Received
April 17, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6110
Review Panel
OB
Submission Type

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