ITind System

Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

Medi-Tate Ltd.

The following data is part of a premarket notification filed by Medi-tate Ltd. with the FDA for Itind System.

Pre-market Notification Details

Device IDK210138
510k NumberK210138
Device Name:ITind System
ClassificationTemporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Applicant Medi-Tate Ltd. 17 Hauman Street Hadera,  IL 3850169
ContactLihi Liviatan
CorrespondentJanice M. Hogan
Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia,  PA  19103
Product CodeQKA  
CFR Regulation Number876.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-19
Decision Date2021-06-25

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