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Company-Registration
1643867828
Device Listing 1643867828
Listing Summary
#
Listing key
1643867828
Premarket submission
K200258
Device
Edwards eSheath Introducer Set
Applicant
Edwards Lifesciences
Product code
DYB
Decision date
2020-03-09
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
57321
2015691
2015691
EDWARDS LIFESCIENCES LLC
1
Y
2026-01-01
ONE EDWARDS WAY IRVINE CA US 92614
117853
3008500478
1713910
Edwards Lifesciences LLC
1
Y
2026-01-01
12050 Lone Peak Parkway Draper UT US 84020
306345
3017298588
3017298588
Denny Kouri
1
N
2026-01-01
One Edwards Way Irvine CA US 92614