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
2069803172
Device Listing 2069803172
Listing Summary
#
Listing key
2069803172
Premarket submission
K160138
Device
Adhesive Electrodes
Applicant
Gmdasz Manufacturing Co., Ltd.
Product code
GXY
Decision date
2016-08-11
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
317489
3027329006
3027329006
AXION USA LLC
1
Y
2026-01-01
120 Raskulinecz Rd Carteret NJ US 07008