FDA 510(k) Application Details - K230804

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K230804
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	JJGC Ind·stria e ComΘrcio de Materiais Dentßrios S.A. Av. Juscelino Kubitschek de Oliveira, 3291 û CIC Curitiba 81270-200 BR Other 510(k) Applications for this Company
Contact	Barbara Uzae 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	03/23/2023
Decision Date	07/07/2023
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