Wound Care Tray a

FDA 510(k) K913480 · Catalina Biomedical Corp.

Substantially Equivalent

510(k) numberK913480

Submission

Device name
Wound Care Tray a
Applicant
Catalina Biomedical Corp.
Duarte, CA, US
Received
August 6, 1991
Decision date
October 18, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MCY – Wound Dressing Kit
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5075
Specialty
General Hospital

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 510(k)s with product code MCY

510(k)DeviceApplicantDecision
K970721Dyna-Flex Multi-Layer Compression SystemMCY · Traditional Johnson & Johnson Medical, Inc.03/21/1997SN
K963719Central Line Dressing Change Tray, Tpn/Cvp Dressing Change TrayMCY · Traditional Grand Medical Products11/27/1996SE
K960585Wound Care Compression System (WCCS)MCY · Traditional Suncoast Medical Products, Inc.04/26/1996SE
K952334Dressing Change TrayMCY · Traditional Busse Hospital Disposables, Inc.07/14/1995SE
K951022Circulon System Step 1MCY · Traditional Convatec, A Division of E.R. Squibb & Sons06/12/1995SESK
K951021Circulon System Step 2MCY · Traditional Convatec, A Division of E.R. Squibb & Sons06/12/1995SESK
K951476E-Pack Procedure KitsMCY · Traditional ETHICON, Inc.05/23/1995SESK
K931932Dressing Change Tray-ModifiedMCY · Traditional Medsurg Industries, Inc.08/27/1993SEKD
K924690Various Non-Sterile Custom Trays/KitsMCY · Traditional Surgipro Central, Inc.07/16/1993SEKD
K923905Wound Dressing KitMCY · Traditional Kit Pak, Inc.07/02/1993SEKD

More from Kit Pak, Inc.

510(k)DeviceDecision
K920050Biolex Wound Gel,MGQ · Traditional 04/07/1992SN
K913479Wound Care Tray BMCY · Traditional 10/08/1991SE
K896358Vari/Moist Wound DressingKGX · Traditional 02/01/1990SN
K896421Transparent Film I.V. Site/Wound DressingKMK · Traditional 01/31/1990SE

Questions and answers

When was Wound Care Tray a cleared by the FDA?

Wound Care Tray a (K913480) received a 510(k) decision of Substantially Equivalent on October 18, 1991, 73 days after the submission was received.

What is the product code of K913480?

The FDA product code is MCY – Wound Dressing Kit, a Class II (moderate risk) device regulated under 21 CFR 880.5075.