Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
2054127421
Device Listing 2054127421
Listing Summary
#
Listing key
2054127421
Premarket submission
K180214
Device
Repris Bladder Injection System
Applicant
Uro-1, Inc.
Product code
FBK
Decision date
2018-05-03
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
316679
3027269340
3027269340
URO-1, INC.
1
N
2026-01-01
3703 Alliance Drive Suite A Greensboro NC US 27407