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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name At Home Intravaginal Insemination System
510(k) Number K232579
Device Name Twoplus Applicator
Applicant
Hannah Life Technologies Pte , Ltd.
Morningstar Centre, 12 New Industrial Rd., #04-05a
Singapore,  SG 536202
Applicant Contact Prusothman M Sina Raja
Correspondent
Matrix Medical Consulting, Inc.
8880 Rio San Diego Dr. Suite 800
San Diego,  CA  92108
Correspondent Contact Alan Donald
Regulation Number884.6110
Classification Product Code
QYZ  
Date Received08/25/2023
Decision Date 12/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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