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510(k) K173103

Pivet and Soft-Pass Embryo Transfer Catheter Sets by Cook Incorporated — Product Code MQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2018
Date Received
September 29, 2017
Clearance Type
Traditional
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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  • K190522 — Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intr (November 14, 2019)
  • K191015 — Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Cat (May 17, 2019)
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