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510(k) Data Aggregation
K Number
K232579Device Name
Twoplus Applicator
Manufacturer
Hannah Life Technologies Pte Ltd.
Date Cleared
2023-12-21
(118 days)
Product Code
QYZ
Regulation Number
884.6110Why did this record match?
Applicant Name (Manufacturer) :
Hannah Life Technologies Pte Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The twoplus Applicator is indicated for over-the-counter home use by individuals who choose not to conceive through intercourse. The twoplus Applicator kit allows for semen collection and the vaginal canal. The twoplus Applicator should be used during the ovulatory phase of the menstrual cycle.
Device Description
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