Med-Tec Hand Grip
FDA 510(k) K954225 · Medtec, Inc.
510(k) numberK954225
Submission
- Device name
- Med-Tec Hand Grip
- Applicant
- Medtec, Inc.
Orange City, IA, US - Received
- September 11, 1995
- Decision date
- November 14, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|---|
| K973842 | Carbon Fiber Conformal Couch TopIXQ · Traditional | Medtec, Inc. | 12/05/1997SE |
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| K946262 | Euro, SCST, Sccft Atlas Radiologic TablesIXQ · Traditional | Scott Imaging Intl., Inc. | 02/15/1995SE |
| K942916 | Octopaque UniversalIXQ · Traditional | Octostop, Inc. | 09/08/1994SE |
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| K923775 | R-Made Head/Arm SupportIXQ · Traditional | R-Made, Inc. | 10/20/1992SE |
| K920729 | Bucky Table BK-12IXQ · Traditional | Shimadzu Medical Systems | 04/27/1992SE |
| K914351 | Clinitron C-10IXQ · Traditional | Ssi Medical Services, Inc. | 02/14/1992SE |
| K912382 | Military Radiographic Flat Table, Cat # T-9130IXQ · Traditional | Continental X-Ray Corp. | 10/10/1991SE |
More from Continental X-Ray Corp.
| 510(k) | Device | Decision |
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| K093738 | MRI Patient Positioning DevicesLNH · Traditional | 05/14/2010SE |
| K974703 | Carbon Fiber Breast BoardIYE · Traditional | 03/10/1998SE |
| K974700 | Matrix MT-MX3IYE · Traditional | 03/04/1998SE |
| K973842 | Carbon Fiber Conformal Couch TopIXQ · Traditional | 12/05/1997SE |
| K962622 | Intra-Oral Thermoplastic ShieldKPY · Traditional | 10/01/1996SE |
| K955236 | Green TEC-2100IWE · Traditional | 05/24/1996SE |
| K954705 | Acrysteel Blocking TrayIYE · Traditional | 01/05/1996SE |
| K954456 | Thermoplastic ShieldKPY · Traditional | 12/21/1995SE |
Questions and answers
When was Med-Tec Hand Grip cleared by the FDA?
Med-Tec Hand Grip (K954225) received a 510(k) decision of Substantially Equivalent on November 14, 1995, 64 days after the submission was received.
What is the product code of K954225?
The FDA product code is IXQ – Table, Radiographic, Stationary Top, a Class II (moderate risk) device regulated under 21 CFR 892.1980.