The following data is part of a premarket notification filed by Medi-tate Ltd. with the FDA for Itind System.
Device ID | K210138 |
510k Number | K210138 |
Device Name: | ITind System |
Classification | Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia |
Applicant | Medi-Tate Ltd. 17 Hauman Street Hadera, IL 3850169 |
Contact | Lihi Liviatan |
Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103 |
Product Code | QKA |
CFR Regulation Number | 876.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-01-19 |
Decision Date | 2021-06-25 |