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Company-Registration
1413774632
Device Listing 1413774632
Listing Summary
#
Listing key
1413774632
Premarket submission
K213992
Device
CombiSet Hemodialysis Blood Tubing Set
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
Product code
FJK
Decision date
2023-05-31
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
17126
1225714
3001451489
Fresenius Medical Care Renal Therapies Group, LLC
1
Y
2026-01-01
920 WINTER STREET Waltham MA US 02451
17128
8030665
3002807744
ERIKA DE REYNOSA, S.A. DE C.V.
1
N
2026-01-01
MIKE ALLEN 1331 PARQUE INDUSTRIAL REYNOSA CD, REYNOSA Tamaulipas MX 88780
225223
3015335038
3015335038
Denise Oppermann
1
N
2026-01-01
920 Winter St Waltham MA US 02451