510(k) K905123

G-TUBE DRESSING CHANGE TRAY by Continental Medical Laboratories, Inc. — Product Code MCY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 27, 1991
Date Received: November 14, 1990
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 Continental Medical Laboratories, Inc.

K964827 — PROD. NO. 01-132 - SUTURE REMOVAL KIT (February 14, 1997)
K963234 — STAPLE REMOVAL KIT (October 21, 1996)
K963443 — PROD. NO. 02-031 - LACERATION TRAY (October 17, 1996)
K962078 — TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER (October 11, 1996)
K954728 — PROD NO. 01-1694 - 4X4 FOAM DRESSING (September 23, 1996)
K962073 — URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY (June 21, 1996)
K952335 — WOUND CARE MANAGEMENT KITS (June 14, 1995)

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)
K923905 — WOUND DRESSING KIT (July 2, 1993)