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
1868442439
Device Listing 1868442439
Listing Summary
#
Listing key
1868442439
Premarket submission
K142397
Device
Predicate III Guidewire
Applicant
Lake Region Medical
Product code
OCY
Decision date
2014-09-19
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
35634
2126666
2126666
Lake Region Medical
1
Y
2026-01-01
340 Lake Hazeltine Dr CHASKA MN US 55318
35635
9681477
3002807439
Charlene Grilletto
1
N
2026-01-01
101 E. Mill Street, Suite P Quakertown Quakertown PA US 18951