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
1688740805
Device Listing 1688740805
Listing Summary
#
Listing key
1688740805
Premarket submission
K991587
Device
BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
Applicant
Helix Medical, Inc.
Product code
EWL
Decision date
1999-06-25
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
34540
2025182
2025182
Freudenberg Medical, LLC
1
N
2026-01-01
1110 Mark Ave CARPINTERIA CA US 93013