RocaTub Ureteral Catheter

Catheter, Ureteral, Gastro-urology

Promepal Sam

The following data is part of a premarket notification filed by Promepal Sam with the FDA for Rocatub Ureteral Catheter.

Pre-market Notification Details

Device IDK192183
510k NumberK192183
Device Name:RocaTub Ureteral Catheter
ClassificationCatheter, Ureteral, Gastro-urology
Applicant Promepal Sam 9 Avenue Albert II Monaco,  MC 98000
ContactMohamed Rekik
CorrespondentMohamed Rekik
Promepal Sam 9 Avenue Albert II Monaco,  MC 98000
Product CodeEYB  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-12
Decision Date2020-04-23

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