FDA 510(k) Application Details - K182067

Device Classification Name	More FDA Info for this Device
510(K) Number	K182067
Device Name	PleuraFlow System with FlowGlide Extra Drainage Length
Applicant	ClearFlow, Inc. 1630 S. Sunkist St. Suite E Anaheim, CA 92806 US Other 510(k) Applications for this Company
Contact	Dov Gal Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2018
Decision Date	08/14/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review