FDA 510(k) Application Details - K013445

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K013445
Device Name	Lenses, Soft Contact, Daily Wear
Applicant	FLORIDA OPTICAL ENGINEERING, INC. 13709 PROGRESS BLVD., BOX 14 ALACHUA, FL 32615 US Other 510(k) Applications for this Company
Contact	RICHARD A GRIFFIN Other 510(k) Applications for this Contact
Regulation Number	886.5925   More FDA Info for this Regulation Number
Classification Product Code	LPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/17/2001
Decision Date	12/26/2001
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