FDA 510(k) Applications Submitted by HOLLISTER, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K100273 01/29/2010 INSTAFLO BOWEL CATHETER SYSTEM KIT HOLLISTER, INC.
K090960 04/06/2009 VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, HOLLISTER, INC.
K083153 10/24/2008 ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 HOLLISTER, INC.
K123804 12/10/2012 INSTAFLO BOWEL CATHETER SYSTEM KIT HOLLISTER, INC.
K013653 11/06/2001 INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE HOLLISTER, INC.
K980976 03/16/1998 AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP HOLLISTER, INC.
K013483 10/19/2001 INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT HOLLISTER, INC.
K980209 01/20/1998 SIMPLICARE THIN FILM WOUND DRESSINGS HOLLISTER, INC.
K960311 01/22/1996 PERINEOMETER HOLLISTER, INC.
K970443 02/05/1997 HOLLISTER RETRACTED PENIS POUCH HOLLISTER, INC.
K990456 02/12/1999 ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP HOLLISTER, INC.
K970602 02/18/1997 VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL HOLLISTER, INC.
K050483 02/24/2005 EVADRI BLADDER CONTROL SYSTEMS HOLLISTER, INC.
K040779 03/26/2004 RESTORE WOUND CLEANSER HOLLISTER, INC.
K991214 04/09/1999 SIMPLICARE TRANSPARENT WOUND DRESSING HOLLISTER, INC.
K971541 04/28/1997 VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON HOLLISTER, INC.
K961872 05/15/1996 INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER HOLLISTER, INC.
K011519 05/17/2001 AMEDA HYGIENIKIT HOLLISTER, INC.
K962537 06/28/1996 INCARE HOT/ICE LITE MACHINE HOLLISTER, INC.
K962900 07/25/1996 SELF RETAINING MALE EXTERNAL URINARY CATHETER HOLLISTER, INC.
K962963 07/30/1996 CHECKMATE ANKLE RESTRAINT SYSTEM HOLLISTER, INC.
K962964 07/30/1996 HEELBO JOHNNY GRAIT BELT SECURITY BELT HOLLISTER, INC.
K963108 08/12/1996 HEELBO QUILTED TORSO RESTRAINT HOLLISTER, INC.
K973023 08/14/1997 INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET HOLLISTER, INC.
K963199 08/15/1996 HEELBO PELVIC RESTRAINT HOLLISTER, INC.
K963222 08/16/1996 MICROGYN PLUS STIMULATION DEVICE HOLLISTER, INC.
K013141 09/20/2001 MICROGYN PLUS STIMULATION DEVICE HOLLISTER, INC.
K964006 10/07/1996 INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) HOLLISTER, INC.
K964057 10/09/1996 INCARE HOT/ICE SYSTEM SHOULDER BLANKET HOLLISTER, INC.
K013345 10/09/2001 INCARE INTERMITTENT CATHETER HOLLISTER, INC.
K974048 10/24/1997 INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER HOLLISTER, INC.
K013612 11/05/2001 INCARE PELVIC FLOOR THERAPY SYSTEM HOLLISTER, INC.


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