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U.S. Department of Health and Human Services

Product Classification
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Device culture, intravaginal, assisted reproduction
Regulation Description Intravaginal culture system.
Definition Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period.
Physical State Polymeric culture device.
Technical Method Culture device designed to hold and maintain gametes and embryos during intravaginal culture procedures.
Target Area Gametes and embryos
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeOYO
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.6165
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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