FDA 510(k) Application Details - K183263

Device Classification Name	More FDA Info for this Device
510(K) Number	K183263
Device Name	UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
Applicant	UNiPACK Medical Corporation 9830 Norwalk Blvd., Suite 100 Santa Fe Springs, CA 90670 US Other 510(k) Applications for this Company
Contact	Joe Pomparelli Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2018
Decision Date	06/14/2019
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