510(k) K232579
- Device
- Twoplus Applicator
- Applicant
- Hannah Life Technologies Pte , Ltd.
- 510(k) number
- K232579
- Product code
- QYZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-21
- Date received
- 2023-08-25
- Regulation
- 884.6110
- Classification name
- At Home Intravaginal Insemination System
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Prusothman M Sina Raja
- Address
- Morningstar Centre, 12 New Industrial Rd., #04-05a Singapore SG 536202 536202
FDA Registration Numbers#
- 1220502
- 1450662
- 3020796587
- 3030595020
- 3014967969
Source Documents#
510(k) summary PDF not indicated by FDA