FDA 510(k) Applications for Medical Device Product Code "LKB"
(Pad, Alcohol, Device Disinfectant)

FDA 510(k) Number Applicant Device Name Decision Date
K080466 122 CORPORATION ALCOHOL PAD 10/21/2008
K833141 ACME UNITED CORP. ONE TIME ACETONE/ALCOHOL;SWAB STICKS 10/31/1983
K833185 APLICARE, INC. ACETONE ALCOHOL PREP PAD 10/31/1983
K833182 APLICARE, INC. APLICARE ALCOHOL PREP PAD 10/27/1983
K833183 APLICARE, INC. APLICARE ONE ACETONE ALCOHOL SWABSTICK 10/31/1983
K833184 APLICARE, INC. APLICARE THREE ALCOHOL SWABSTICKS 10/27/1983
K890514 BAUSCH & LOMB, INC. PRE-MOISTENED CLEANSING PAD 04/10/1989
K813391 BECKMAN INSTRUMENTS, INC. TOBRAMYCIN REAGENT TEST KIT 12/18/1981
K121655 BECTON DICKINSON & CO. BD ALCOHOL SWAB 03/20/2013
K896898 BOWEN & COMPANY, INC. BOWEN ELECTRODE SKIN PREPATORY CLEANSER 04/04/1990
K093229 CATHETER CONNECTIONS, INC. CATHETER CONNECTIONS DUALCAP 04/08/2010
K123065 CATHETER CONNECTIONS, INC. CATHETER CONNECTIONS DUALCAP SOLO 12/14/2012
K123967 CATHETER CONNECTIONS, INC. CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS 01/22/2013
K112985 CATHETER CONNECTIONS, INC. CATHETER CONNECTIONS' DUALCAP DUO 11/09/2011
K113842 CATHETER CONNECTIONS, INC. CATHETER CONNECTIONS' DUALCAP SOLO 01/27/2012
K142806 CATHETER CONNECTIONS, INC. DualCap 05/22/2015
K142399 CATHETER CONNECTIONS, INC. DualCap IV Pole Strips(Disinfectant Caps for Male Luers) 11/19/2014
K830330 CEDERROTH, INC. USA SAVETT ALCOHOL PREP 03/17/1983
K833936 CONCORD LABORATORIES, INC. ACETONE ALCOHOL SWABS 01/30/1984
K833993 CONCORD LABORATORIES, INC. ALCOHOL SWABS 01/30/1984
K883840 CONCORD LABORATORIES, INC. DRI-VENT ARTERIAL BLOOD SAMPLING KIT 05/16/1989
K112791 CR BARD SITESCRUB IPA DEVICE 02/24/2012
K852235 ELLIS PHARMACEUTICAL CONSULTING, INC. STERETS INJECTION SWAB 06/07/1985
K083508 EXCELSIOR MEDICAL CORP. SWABCAP 04/28/2009
K860961 H & P INDUSTRIES, INC. GAMMA RADIATION STERILIZED ALCOHOL PREP PADS 04/09/1986
K892193 HOLTSCH CO., INC. QUICKPAD (ALCOHOL SWABS) 08/04/1989
K080579 HOSPIRA, INC. EFFECTIVE (TM) CAP 09/11/2008
K110826 IVERA MEDICAL CUROS PORT PROTECTOR 06/23/2011
K111992 IVERA MEDICAL, INC. CUROS PORT PROTECTOR 01/12/2012
K140657 IVERA MEDICAL, INC. CUROS RED PORT PROTECTOR 12/04/2014
K121171 IVERA MEDICAL, INC. CUROS TIP 11/26/2012
K912161 MEDICAL DEVICE INSPECTION CO., INC. I.V. STARR KIT 10/08/1991
K896835 NORPAK MFG., INC. ALCOHOL PREP AND POVIDONE-IODINE PREP 01/11/1990
K132380 PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. PREVANTICS DEVICE SWAB 08/27/2014
K870718 SPAN-AMERICA MEDICAL SYSTEMS, INC. AMERICAN ALCOHOL PREP PAD STERILE MEDIUM 05/07/1987
K893958 SPAN-AMERICA MEDICAL SYSTEMS, INC. BAXTER ACETONE-ALCOHOL PREP PADS, STERILE 10/03/1989
K894791 SPAN-AMERICA MEDICAL SYSTEMS, INC. BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE 10/03/1989
K910735 SPECIALITES SEPTODONT HEXIDIS ALCOHOL SWAB 04/02/1991
K912731 WESTLOCK INVESTMENTS (USA), INC. STERI-SWAB 10/02/1991


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