FDA 510(k) Application Details - K231219

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K231219
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	Nobel Biocare Services AG Balz Zimmermann-Str. 7 Kloten 8302 CH Other 510(k) Applications for this Company
Contact	Bernice Jim 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	04/28/2023
Decision Date	06/27/2023
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