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Device Listing 1759978057

Listing Summary#

Listing key
1759978057
Premarket submission
K190589
Device
Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
Applicant
Cochlear Americas
Product code
PFO
Decision date
2019-07-03