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Company-Registration
1180042780
Device Listing 1180042780
Listing Summary
#
Listing key
1180042780
Premarket submission
K231534
Device
5008X Hemodialysis System
Applicant
Fresenius Medical Care
Product code
KDI
Decision date
2024-02-02
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
9413
9611823
3002807005
Denise Oppermann
1
N
2026-01-01
920 Winter St Waltham MA US 02451
234722
3016096143
3016096143
TST GmbH
1
N
2026-01-01
Marie-Curie-Str. 1a Gernsheim Hesse DE 64579
336344
3035708507
3035708507
Denise Oppermann
1
N
2026-01-01
920 Winter St North Waltham MA US 02451
345254
3043014136
3043014136
Denise Oppermann
1
N
2026-01-01
920 Winter St North Waltham MA US 02451