FDA 510(k) Application Details - K160574

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K160574
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG MAINZER STR 346 BINGEN AM RHEIN 55411 DE Other 510(k) Applications for this Company
Contact	RICHARD DONACA 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	03/01/2016
Decision Date	12/20/2016
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