FDA 510(k) Application Details - DEN100017

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN100017
Device Name	LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
Applicant	TEARSCIENCE, INC. 1101 G AVIATION PKWY MORRISVILLE, NC 27560 US Other 510(k) Applications for this Company
Contact	CHRISTY MOENY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ORZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2010
Decision Date	06/28/2011
Decision	DENG -
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review