FDA 510(k) Application Details - K241378

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K241378
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	S.I.N. - Sistema de Implante Nacional S.A. Avenida Vereador Abel Ferreira, 2140 Sπo Paulo Rua Soldado Ocimar Guimarπes da Silva, 421 Sπo Paulo 03340000 BR Other 510(k) Applications for this Company
Contact	Denise Domiciano 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	05/15/2024
Decision Date	07/12/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review