FDA 510(k) Applications Submitted by DEBRA KETCHUM

FDA 510(k) Number Submission Date Device Name Applicant
K080755 03/17/2008 SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS BAUSCH & LOMB, INC.
K071043 04/12/2007 BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES BAUSCH & LOMB, INC.
K061157 04/26/2006 SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS BAUSCH & LOMB
K011718 06/04/2001 BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT BAUSCH & LOMB, INC.
K073184 11/13/2007 BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS BAUSCH & LOMB, INC.
K040204 01/29/2004 ZYOPTIX XP MICROKERATOME BAUSCH & LOMB, INC.
K001960 06/27/2000 RIGID GAS PERMEABLE CONTACT LENS POLYMER TECHNOLOGY
K002025 07/03/2000 RIGID GAS PERMEABLE CONTACT LENS POLYMER TECHNOLOGY
K022128 07/01/2002 BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS BAUSCH & LOMB INCORPORATED
K020927 03/21/2002 BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS BAUSCH & LOMB
K980133 01/15/1998 BAUSCH & LOMB WETTING AND SOAKING SOLUTION POLYMER TECHNOLOGY CORP.
K980741 02/26/1998 BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B) POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
K000795 03/13/2000 RIGID GAS PERMEABLE CONTACT LENS POLYMER TECHNOLOGY
K011945 06/21/2001 RIGID GAS PERMEABLE CONTACT LENS SOLUTION POLYMER TECHNOLOGY CORP.
K962512 06/27/1996 BOSTON CONTACT LENS CASE POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
K983836 10/30/1998 RIGID GAS PERMEABLE CONTACT LENS SOLUTION POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
K013762 11/13/2001 RIGID GAS PERMEABLE CONTACT LENS BAUSCH & LOMB INCORPORATED


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