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
1646111131
Device Listing 1646111131
Listing Summary
#
Listing key
1646111131
Premarket submission
K011366
Device
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
Applicant
Siemens Hearing Instruments, Inc.
Product code
KLW
Decision date
2001-06-01
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
227037
2217809
2217809
SIVANTOS, INC.
1
Y
2020-04-25
10 Constitution Ave PISCATAWAY NJ US 08854
20782
3003426343
3003426343
SIVANTOS PTE LTD
1
N
2026-01-01
18 TAI SENG STREET #08-08 Singapore South East SG 539775
163329
3007595838
3007595838
Jon Schirado
1
N
2020-04-25
ATRIA Corporate Center, Suite W125 3033 Campus Drive Plymouth MN US 55441