FDA 510(k) Application Details - K242023

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K242023
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	Implant Microdent System S.L.U. C/Carles Bu"igues, 1 1 Pol. Ind. Can Magre Santa Eulalia de Ronτana 08187 ES Other 510(k) Applications for this Company
Contact	Joan Mu±oz 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	07/11/2024
Decision Date	02/19/2025
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