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510(k) K222932

INVOcell Intravaginal Culture System by Invo Bioscience — Product Code OYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2023
Date Received
September 26, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture, Intravaginal, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6165
Review Panel
OB
Submission Type

Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period.

Other clearances by Invo Bioscience

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