510(k) K231645
- Device
- PherDal® At-Home Insemination Kit
- Applicant
- Pherdal Fertility Science, Inc.
- 510(k) number
- K231645
- Product code
- QYZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-14
- Date received
- 2023-06-05
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dr. Jennifer Hintzsche Westphal
- Address
- 405 W 2nd St., Unit 1141 Dixon IL US 61021 61021
FDA Registration Numbers#
- 1220502
- 1450662
- 3020796587
- 3030595020
- 3014967969