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510(k) K932310

KIT PAK INCONTINENT SKIN CARE KIT by Kit Pak, Inc. — Product Code EYQ

K932310 is an FDA 510(k) premarket notification submitted by Kit Pak, Inc. for the device "KIT PAK INCONTINENT SKIN CARE KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on June 1, 1994. The device falls under product code EYQ (Garment, Protective, For Incontinence), a Class I device regulated under 21 CFR 876.5920. Kit Pak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
June 1, 1994
Date Received
May 11, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Garment, Protective, For Incontinence
Device Class
Class I
Regulation Number
876.5920
Review Panel
GU
Submission Type

Other clearances by Kit Pak, Inc.

  • K942959 — KIT PAK WET SALINE DRESSING (February 14, 1995)
  • K941499 — KIT PAK DRESSING CHANGE TRAY (July 20, 1994)
  • K934080 — URINARY DRAINAGE BAG (May 18, 1994)
  • K931013 — FOLEY CATHETER TRAY (August 9, 1993)
  • K923905 — WOUND DRESSING KIT (July 2, 1993)
  • K924051 — KIT PAK I.V. START KIT (June 22, 1993)
  • K923906 — FOLEY INSERTION TRAY (June 22, 1993)
  • K922051 — KIT PAK'S FLUSHING KIT (June 17, 1993)
  • K925281 — KIT PAK URINARY CARE SUPPLIES (April 19, 1993)
  • K900148 — KIT PAK IRRIGATION TRAY (April 23, 1990)

Other clearances for product code EYQ

  • K950784 — DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM (May 3, 1995)
  • K903342 — DEODORIZING AND SOUND MUFFLING ANAL PAD (October 23, 1990)
  • K891686 — LIB SYSTEM, BABY/ADULT DIAPER (May 31, 1989)
  • K885185 — INTERA SHIELD AND INTERA UNDERGARMENT (February 8, 1989)
  • K883894 — DRIPRIDE PROVIDE SLIM (January 30, 1989)
  • K883895 — DRIPRIDE ULTRA INCONTINENT PAD (January 30, 1989)
  • K883787 — REUSABLE ADULT INCONTINENT DIAPER (November 7, 1988)
  • K882418 — DRY COMFORT UNDERGARMENT (September 29, 1988)
  • K880454 — AT EASE STRESS PAD (June 16, 1988)
  • K880455 — AT EASE ADULT DIAPER (April 14, 1988)

FDA data resources