FDA 510(k) Application Details - K161673

Device Classification Name	Plug, Punctum   More FDA Info for this Device
510(K) Number	K161673
Device Name	Plug, Punctum
Applicant	LACRIMEDICS, INC. 2620 WILLIAMSON PLACE NW, SUITE 113 DUPONT, WA 98245 US Other 510(k) Applications for this Company
Contact	REBECCA C. DUTTON Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LZU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2016
Decision Date	11/18/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review