510(k) K241897
- Device
- MOR
- Applicant
- Morari, Inc.
- 510(k) number
- K241897
- Product code
- QRC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-11
- Date received
- 2024-06-28
- Regulation
- 876.5026
- Classification name
- Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jeff Bennett
- Address
- 6501 Zircon Ln. Maple Grove MN US 55311 55311
FDA Registration Numbers#
- 3017709633
- 3020659203