Bausch Lomb Surgical Inc 1400 N Goodman St Rochester Ny 14609 Pma Numberp850059 Supplement Numbers008 Date Received08 22 1988 Decision Date10 03 1988 Withdrawal Date 11 26 2008 Product Code Hql Advisory Committee Ophthalmic Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Bausch Lomb Surgical Inc 1400 N Goodman St Rochester Ny 14609 Pma Numberp850059 Supplement Numbers008 Date Received08 22 1988 Decision Date10 03 1988 Withdrawal Date 11 26 2008 Product Code Hql Advisory Committee Ophthalmic Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P850059S008 BAUSCH & LOMB SURGICAL, INC.1400 N. Goodman St.rochester, NY 14609 PMA NumberP850059 Supplement NumberS008 Date Received08/22/1988 Decision Date10/03/1988 Withdrawal Date 11/26/2008 Product Code HQL  Advisory Committee Ophthalmic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	KELMAN(TM) OMNIFIT II MODEL 2100	1988-10-03