Carbon Lights Hand Surgery Table
FDA 510(k) K944779 · Allen Medical Systems, Inc.
510(k) numberK944779
Submission
- Device name
- Carbon Lights Hand Surgery Table
- Applicant
- Allen Medical Systems, Inc.
Bedford Heights, OH, US - Received
- September 27, 1994
- Decision date
- October 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FWZ – Operating Room Accessories Table Tray
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4950
- Specialty
- General, Plastic Surgery
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.
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960019 | Retractor Arm ClampFWZ · Traditional | Biopsys Medical, Inc. | 02/09/1996SE |
| K945415 | 'Lil Mac Accessory Clamp(Tm)FWZ · Traditional | D.L. Nelson and Assoc., Inc. | 11/22/1994SE |
| K935381 | Kaps Positioning ArmFWZ · Traditional | Andronic Devices, Ltd. | 04/15/1994SE |
| K931037 | Whitmore Vacuum-Lock Spinal Frame (VLSF-100)FWZ · Traditional | Whitmore Ent., Inc. | 07/30/1993SE |
| K926225 | Sponge CounterFWZ · Traditional | American Medical Manufacturer, Inc. | 03/05/1993SE |
| K925035 | Midkiff Geostatic ClampFWZ · Traditional | D.L. Nelson and Assoc., Inc. | 02/18/1993SE |
| K905565 | Lateral Buttress SupportFWZ · Traditional | Mcconnell Orthopedic | 02/21/1991SE |
| K905564 | Prep and Operating StandFWZ · Traditional | Mcconnell Orthopedic | 02/21/1991SE |
| K910031 | Park City Shoulder PositionerFWZ · Traditional | Orthopedic Systems, Inc. | 01/24/1991SE |
| K904826 | Tko Telescoping Lithotomy StirrupFWZ · Traditional | D.L. Nelson and Assoc., Inc. | 10/31/1990SE |
More from D.L. Nelson and Assoc., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971988 | Allen, Ultra and Smart SocketsFQO · Traditional | 07/11/1997SE |
| K964273 | Dura-Board ArmboardGDC · Traditional | 01/08/1997SE |
| K960027 | High Volume I.V. & Irrigation TowerFOX · Traditional | 03/12/1996SE |
| K921168 | Allen Infusion Pump Model 3000 and Irrigation 2000KZD · Traditional | 04/21/1993SE |
Questions and answers
When was Carbon Lights Hand Surgery Table cleared by the FDA?
Carbon Lights Hand Surgery Table (K944779) received a 510(k) decision of Substantially Equivalent on October 14, 1994, 17 days after the submission was received.
What is the product code of K944779?
The FDA product code is FWZ – Operating Room Accessories Table Tray, a Class I (low risk) device regulated under 21 CFR 878.4950.