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
1639228140
Device Listing 1639228140
Listing Summary
#
Listing key
1639228140
Premarket submission
K181507
Device
PREVENA RESTOR(TM) Incision Management System
Applicant
Kci USA, Inc.
Product code
OMP
Decision date
2019-02-15
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
148738
3010173425
3002807036
Synergy Health Westport Ltd
1
N
2026-01-01
Lodge Road Westport Mayo IE Westport