FDA 510(k) Application Details - K203394

Device Classification Name	More FDA Info for this Device
510(K) Number	K203394
Device Name	PleuraFlow System with FlowGlide
Applicant	ClearFlow, Inc, 140 Technology Drive Suite 100 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Serrah Namini 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	11/18/2020
Decision Date	03/02/2021
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