FDA 510(k) Application Details - K140711

Device Classification Name	Plug, Punctum   More FDA Info for this Device
510(K) Number	K140711
Device Name	Plug, Punctum
Applicant	PARAGON BIOTECK, INC. 4640 SW MACADAM, STE 80 PORTLAND, OR 97239 US Other 510(k) Applications for this Company
Contact	LAUREN M-C BLUETT 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	03/21/2014
Decision Date	06/20/2014
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