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Data / Medical devices / United States / Premier Sperm Donors LLC

Premier Sperm Donors LLC: FDA-registered device maker in Austin, TX, United States, 1 510(k) clearance

Premier Sperm Donors LLC is registered with the FDA (registration 3030595020) in Austin, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 29, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3030595020
Address
1611 Cloverleaf Dr, Austin, TX, United States, 78723
Owner or operator
Premier Sperm Donors (10094644)
Roles
Complaint file establishment, Specification developer
First device listed
December 12, 2025
Registered through
2026
Brand names listed
Mosie Baby

Devices it lists

DeviceProduct codeClassRoleSource
At Home Intravaginal Insemination SystemQYZ2Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 29, 2023K231203Mosie Baby KitQYZSubstantially EquivalentMosie Babyaccessdata.fda.gov

Compare with other makers

Updated November 29, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.