FDA 510(k) Application Details - K163556

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K163556
Device Name	Drape, Surgical
Applicant	COVALON TECHNOLOGIES, INC. 1660 TECH AVENUE UNIT 5 MISSISSSAUGA L4W 5S7 CA Other 510(k) Applications for this Company
Contact	KIM CROOKS Other 510(k) Applications for this Contact
Regulation Number	878.4370   More FDA Info for this Regulation Number
Classification Product Code	KKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2016
Decision Date	09/14/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review