Home / 510(k) Clearances / K941499

510(k) K941499

KIT PAK DRESSING CHANGE TRAY by Kit Pak, Inc. — Product Code KGX

K941499 is an FDA 510(k) premarket notification submitted by Kit Pak, Inc. for the device "KIT PAK DRESSING CHANGE TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on July 20, 1994. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Kit Pak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
July 20, 1994
Date Received
March 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

Other clearances by Kit Pak, Inc.

  • K942959 — KIT PAK WET SALINE DRESSING (February 14, 1995)
  • K932310 — KIT PAK INCONTINENT SKIN CARE KIT (June 1, 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 KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • K972914 — SYVEK PATCH (December 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K952606 — TARGETT PATCH (December 21, 1995)
  • K954007 — PARALLEL (November 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (October 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)

FDA data resources