FDA 510(k) Application Details - K150042

Device Classification Name	More FDA Info for this Device
510(K) Number	K150042
Device Name	PleuraFlow System
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	01/09/2015
Decision Date	06/02/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review