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
1014820293
Device Listing 1014820293
Listing Summary
#
Listing key
1014820293
Premarket submission
K140088
Device
PHANTOM XL INSULATED DILATORS
Applicant
Tedan Surgical Innovations, LLC
Product code
PDQ
Decision date
2014-09-25
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
33205
1038445
1038445
Centurion Medical Products Corporation
1
N
2020-04-25
3310 S Main St SALISBURY NC US 28147
33206
1824619
1824619
CENTURION MEDICAL PRODUCTS, LP
1
N
2026-01-01
301 Catrell Dr HOWELL MI US 48843
33209
3004519921
3005846326
KAREN KOWALCZYK KOWALCZYK
1
N
2026-01-01
100 Centurion Way Williamston MI US 48895