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510(k) K922051

KIT PAK'S FLUSHING KIT by Kit Pak, Inc. — Product Code KOD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
June 17, 1993
Date Received
May 1, 1992
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 Kit Pak, Inc.

  • K942959 — KIT PAK WET SALINE DRESSING (February 14, 1995)
  • K941499 — KIT PAK DRESSING CHANGE TRAY (July 20, 1994)
  • 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)
  • K923906 — FOLEY INSERTION TRAY (June 22, 1993)
  • K924051 — KIT PAK I.V. START KIT (June 22, 1993)
  • K925281 — KIT PAK URINARY CARE SUPPLIES (April 19, 1993)
  • K900148 — KIT PAK IRRIGATION TRAY (April 23, 1990)

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