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Company-Registration
2032634573
Device Listing 2032634573
Listing Summary
#
Listing key
2032634573
Premarket submission
K251910
Device
Focal OneĀ®
Applicant
Edap Technomed, Inc.
Product code
PLP
Decision date
2025-11-19
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
139797
1287394
1287394
Edap Technomed Inc.
1
Y
2026-01-01
5321 Industrial Oaks Blvd Suite 110 Austin TX US 78735