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
1689036405
Device Listing 1689036405
Listing Summary
#
Listing key
1689036405
Premarket submission
K901789
Device
PALADON(R) 65
Applicant
Kulzer, Inc.
Product code
EBI
Decision date
1990-06-22
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
21764
9610902
3002807166
KULZER GMBH
1
N
2026-01-01
PHILIPP-REIS-STRASSE 8/13 WEHRHEIM Hesse DE D-61273
21766
3005665377
3005665377
David Vincent
1
N
2026-01-01
4315 S Lafayette Blvd South Bend IN US 46614
176134
3011203516
3011203516
David Vincent
1
N
2026-01-01
4315 S Lafayette Blvd South Bend IN US 46614