FDA.reportPublic FDA data

Dinamarie Stefani

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30381385223038138522Dinamarie Stefani1N2027-01-013052 Orchard Dr San Jose CA US 95134

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3380501919025444K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)KDI2026-01-26
3380501115839561K233335Tablo® Hemodialysis SystemKDI2023-12-05
3380501202292973K232776Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerKDI2024-05-03
3380501619670028K223248Tablo® Hemodialysis SystemKDI2023-06-21
3380501314545143K211370Tablo Hemodialysis SystemKDI2022-07-29
3380501293092549K210782Tablo CartridgeFJK2021-11-26
3380501414581063K200741Tablo Hemodialysis SystemKDI2020-03-31
3380501637956625K190793Tablo Hemodialysis System, Tablo CartridgeKDI2019-12-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KDI72026-01-26
FJK12021-11-26