FDA 510(k) Application Details - K243317

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K243317
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	Infinitum Eta Ltd. Hatnufa St. 6 Petach Tikva 4951024 IL Other 510(k) Applications for this Company
Contact	Avital Barlev 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	10/22/2024
Decision Date	02/11/2025
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