510(k) DEN190020
- Device
- iTind System
- Applicant
- Medi-Tate , Ltd.
- 510(k) number
- DEN190020
- Product code
- QKA
- Decision
- Unknown (DENG)
- Decision date
- 2020-02-25
- Date received
- 2019-04-02
- Regulation
- 876.5510
- Classification name
- Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Lihi Liviatan
- Address
- 14 Hailan St. Or-Akiva IL 3060000 3060000
FDA Registration Numbers#
- 2024311
- 3016677053
- 3013944123
- 3008791915
- 3008729892
- 9610773
Source Documents#
510(k) summary PDF not indicated by FDA