FDA 510(k) Application Details - K223672

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K223672
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	Cochlear 10350 Park Meadows Drive Lone Tree, CO 80124 US Other 510(k) Applications for this Company
Contact	Denis DiMartino Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	KCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/2022
Decision Date	03/21/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review