FDA 510(k) Application Details - K061398

Device Classification Name	Plug, Punctum   More FDA Info for this Device
510(K) Number	K061398
Device Name	Plug, Punctum
Applicant	FCI OPHTHALMICS, INC. 344 ANNABELLE POINT RD. CENTERVILLE, MA 02632-2402 US Other 510(k) Applications for this Company
Contact	HILLARD W WELCH 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	05/19/2006
Decision Date	07/11/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review