FDA 510(k) Application Details - K133127

Device Classification Name	More FDA Info for this Device
510(K) Number	K133127
Device Name	LIPIFLOW THERMAL PULSATION SYSTEM
Applicant	TEARSCIENCE, INC. 5151 MCCRIMMON PARKWAY SUITE 250 MORRISVILLE, NC 27560 US Other 510(k) Applications for this Company
Contact	CHRISTY STEVENS, OD, MPH 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	09/30/2013
Decision Date	12/23/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review