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Company-Registration
1086820842
Device Listing 1086820842
Listing Summary
#
Listing key
1086820842
Premarket submission
K261853
Device
Gepotidacin GEP 10 µg
Applicant
Liofilchem, Inc.
Product code
JTN
Decision date
2026-07-23
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
196334
3012389632
3012389632
LIOFILCHEM S.R.L.
1
N
2026-01-01
Via Scozia, Zona Industriale Roseto degli Abruzzi Teramo IT 64026
212624
3013661582
3013661582
Liofilchem, Inc.
1
Y
2026-01-01
465 Waverley Oaks Rd. Suite 317 Waltham MA US 02452