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510(k) K232579

Twoplus Applicator by Hannah Life Technologies Pte , Ltd. — Product Code QYZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 21, 2023
Date Received: August 25, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: At Home Intravaginal Insemination System
Device Class: Class II
Regulation Number: 884.6110
Review Panel: OB
Submission Type

To deliver semen to the vaginal canal for insemination.