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
1927687219
Device Listing 1927687219
Listing Summary
#
Listing key
1927687219
Premarket submission
K153521
Device
IH Implant System
Applicant
Sewonmedix, Inc.
Product code
DZE
Decision date
2016-10-14
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
200486
3013271380
3013271380
April Lee
1
N
2026-01-01
106 Superior Irvine CA US 92620