Central Line Dressing Change Tray, Tpn/Cvp Dressing Change Tray
FDA 510(k) K963719 · Grand Medical Products
510(k) numberK963719
Submission
- Device name
- Central Line Dressing Change Tray, Tpn/Cvp Dressing Change Tray
- Applicant
- Grand Medical Products
Schaumburg, IL, US - Received
- September 16, 1996
- Decision date
- November 27, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K970721 | Dyna-Flex Multi-Layer Compression SystemMCY · Traditional | Johnson & Johnson Medical, Inc. | 03/21/1997SN |
| K960585 | Wound Care Compression System (WCCS)MCY · Traditional | Suncoast Medical Products, Inc. | 04/26/1996SE |
| K952334 | Dressing Change TrayMCY · Traditional | Busse Hospital Disposables, Inc. | 07/14/1995SE |
| K951022 | Circulon System Step 1MCY · Traditional | Convatec, A Division of E.R. Squibb & Sons | 06/12/1995SESK |
| K951021 | Circulon System Step 2MCY · Traditional | Convatec, A Division of E.R. Squibb & Sons | 06/12/1995SESK |
| K951476 | E-Pack Procedure KitsMCY · Traditional | ETHICON, Inc. | 05/23/1995SESK |
| K931932 | Dressing Change Tray-ModifiedMCY · Traditional | Medsurg Industries, Inc. | 08/27/1993SEKD |
| K924690 | Various Non-Sterile Custom Trays/KitsMCY · Traditional | Surgipro Central, Inc. | 07/16/1993SEKD |
| K923905 | Wound Dressing KitMCY · Traditional | Kit Pak, Inc. | 07/02/1993SEKD |
| K926063 | Per-Q-Cath Dressing Change TrayMCY · Traditional | Gesco Intl., Inc. | 06/07/1993SEKD |
More from Gesco Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K963724 | Gauze Sponge, Non X-Ray DetectableEFQ · Traditional | 11/29/1996SN |
| K963723 | Laceration TrayLRP · Traditional | 11/27/1996SE |
| K963722 | IV Start KitLRS · Traditional | 11/27/1996SE |
| K963721 | Skin Scrub TrayLRO · Traditional | 11/27/1996SE |
| K963720 | Tracheostomy KitLRQ · Traditional | 11/27/1996SE |
| K963715 | Debridement Tray, Incision and Drainage TrayLRO · Traditional | 11/27/1996SE |
| K963714 | Grand Medical Suture Removal KitMCZ · Traditional | 11/27/1996SE |
Questions and answers
When was Central Line Dressing Change Tray, Tpn/Cvp Dressing Change Tray cleared by the FDA?
Central Line Dressing Change Tray, Tpn/Cvp Dressing Change Tray (K963719) received a 510(k) decision of Substantially Equivalent on November 27, 1996, 72 days after the submission was received.
What is the product code of K963719?
The FDA product code is MCY – Wound Dressing Kit, a Class II (moderate risk) device regulated under 21 CFR 880.5075.