FDA 510(k) Application Details - K190589

Device Classification Name	More FDA Info for this Device
510(K) Number	K190589
Device Name	Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
Applicant	Cochlear Americas 13059 E. Peakview Avenue Centennial, CO 80111 US Other 510(k) Applications for this Company
Contact	Laura Blair Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PFO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2019
Decision Date	07/03/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review