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510(k) K013483

INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT by Hollister, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2002
Date Received
October 19, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Hollister, Inc.

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  • K090960 — VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 7208 (August 20, 2009)
  • K083153 — ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 (February 4, 2009)
  • K050483 — EVADRI BLADDER CONTROL SYSTEMS (April 12, 2005)
  • K040779 — RESTORE WOUND CLEANSER (May 17, 2004)
  • K013612 — INCARE PELVIC FLOOR THERAPY SYSTEM (March 19, 2002)
  • K013653 — INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE (March 5, 2002)
  • K013345 — INCARE INTERMITTENT CATHETER (January 7, 2002)
  • K013141 — MICROGYN PLUS STIMULATION DEVICE (December 19, 2001)

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