FDA 510(k) Application Details - K182084

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K182084
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	Sweden & Martina S.p.A. via Veneto 10 Due Carrare 35020 IT Other 510(k) Applications for this Company
Contact	Alessia Pezzato 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	08/02/2018
Decision Date	11/04/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review