FDA 510(k) Application Details - K162361

Device Classification Name	Plug, Punctum   More FDA Info for this Device
510(K) Number	K162361
Device Name	Plug, Punctum
Applicant	OASIS MEDICAL, INC. 514 S. VERMONT AVENUE GLENDORA, CA 91741 US Other 510(k) Applications for this Company
Contact	JAMES CHRISTENSEN 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	08/23/2016
Decision Date	04/17/2017
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