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Device Listing 1657766126

Listing Summary#

Listing key
1657766126
Premarket submission
K231204
Device
Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App
Applicant
Cochlear
Product code
PFO
Decision date
2023-08-18