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510(k) K220010

Daylily Single Use Sterile Embryo Transfer Catheter by Shanghai Horizon Medical Technology Co., Ltd. — Product Code MQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2022
Date Received
January 4, 2022
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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