FDA 510(k) Application Details - K181174

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K181174
Device Name	Wrap, Sterilization
Applicant	Cardinal Health 200 LLC 3651 Birchwood Drive Waukegan, IL 60085 US Other 510(k) Applications for this Company
Contact	Jillian Connery Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	FRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2018
Decision Date	12/11/2018
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