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510(k) K232493

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) by Wuhan Huchuang Union Technology Co., Ltd. — Product Code MQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2024
Date Received
August 17, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6120
Review Panel
OB
Submission Type

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