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
1188774795
Device Listing 1188774795
Listing Summary
#
Listing key
1188774795
Premarket submission
K181011
Device
AIM2
Applicant
GC America, Inc.
Product code
ELW
Decision date
2018-07-12
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
10508
1410097
1410097
GC AMERICA INC.
1
Y
2026-01-01
3737 W 127th St ALSIP IL US 60803
10517
9612300
3002808289
GC CORP.
1
N
2026-01-01
76-1 HASUNUMA-CHO ITABASHI-KU Tokyo JP 174-8585
10516
3002807050
3002807050
GC CORPORATION-FUJI OYAMA FACTORY
1
N
2026-01-01
584-1 NAKAHINATA OYAMA-CHO SUNTO-GUN, Shizuoka-Ken JP 410-1307