510(k) K923905

WOUND DRESSING KIT by Kit Pak, Inc. — Product Code MCY

Clearance Details

Decision: SEKD (Substantially Equivalent (kit, denovo))
Decision Date: July 2, 1993
Date Received: August 4, 1992
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Wound Dressing Kit
Device Class: Class II
Regulation Number: 880.5075
Review Panel: SU
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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)
K923906 — FOLEY INSERTION TRAY (June 22, 1993)
K924051 — KIT PAK I.V. START KIT (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 MCY

K970721 — DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM (March 21, 1997)
K963719 — CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY (November 27, 1996)
K960585 — WOUND CARE COMPRESSION SYSTEM (WCCS) (April 26, 1996)
K952334 — DRESSING CHANGE TRAY (July 14, 1995)
K951021 — CIRCULON SYSTEM STEP 2 (June 12, 1995)
K951022 — CIRCULON SYSTEM STEP 1 (June 12, 1995)
K951476 — E-PACK PROCEDURE KITS (May 23, 1995)
K931932 — DRESSING CHANGE TRAY-MODIFIED (August 27, 1993)
K924690 — VARIOUS NON-STERILE CUSTOM TRAYS/KITS (July 16, 1993)
K925021 — TPN TRAY (STERILE) (June 7, 1993)