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
2008389501
Device Listing 2008389501
Listing Summary
#
Listing key
2008389501
Premarket submission
K203066
Device
COOLIEF Cooled Radiofrequency Kit Advanced
Applicant
Avanos Medical, Inc.
Product code
GXI
Decision date
2020-12-22
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
300075
9680425
3007596547
Avent S. de R.L. de C.V.
1
N
2026-01-01
Ave Noruega Edificio D-1B Fraccionamiento, Rubio TIJUANA Baja California MX 22116
175092
3011270181
3011270181
Avanos Medical, Inc.
1
Y
2026-01-01
5405 Windward Parkway Alpharetta GA US 30004