Orex Medical Bedding
FDA 510(k) K944953 · Thantex Specialties, Inc.
510(k) numberK944953
Submission
- Device name
- Orex Medical Bedding
- Applicant
- Thantex Specialties, Inc.
Herndon, VA, US - Received
- October 7, 1994
- Decision date
- December 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KME – Bedding, Disposable, Medical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6060
- Specialty
- General Hospital
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042145 | Ready-Heat BlanketKME · Traditional | Techtrade, LLC | 09/17/2004SE |
| K933636 | Dispose-A-SheetKME · Traditional | Belmac Healthcare Corp. | 01/26/1994SE |
| K932539 | Doctor Down --Rescue WrapKME · Traditional | Three Dog Down | 11/02/1993SE |
| K922143 | American Burn SheetKME · Traditional | American Silk Sutures, Inc. | 08/10/1992SE |
| K915303 | Foil Baby BuntingKME · Traditional | Gam Industries, Inc. | 02/20/1992SE |
| K912257 | Chem-Sleeve BKME · Traditional | Haz-Med, Inc. | 12/31/1991SE |
| K911953 | Medi Guard Sheets/UnderlaysKME · Traditional | Sancella, Inc. | 05/28/1991SE |
| K911952 | Medi Guard UnderpadKME · Traditional | Sancella, Inc. | 05/28/1991SE |
| K911948 | Medi Guard PillowcaseKME · Traditional | Sancella, Inc. | 05/28/1991SE |
| K911950 | Medi Guard DrapesKME · Traditional | Sancella, Inc. | 05/21/1991SE |
More from Sancella, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970547 | Isolyser SDS Sharps ContainerFMI · Traditional | 07/18/1997SE |
| K961083 | Orex Surgeon's VestFYA · Traditional | 08/23/1996SE |
| K942200 | Isolyser Orex Surgeon's Caps, Hoods, Bouffant CapsLYU · Traditional | 08/07/1995SE |
| K943626 | Isolyser Sharps Management System SMSFMI · Traditional | 06/16/1995SE |
| K945755 | Orex(R) O.R Equipment DrapesKKX · Traditional | 05/25/1995SE |
| K945223 | Orex Isolation GownFYC · Traditional | 04/25/1995SE |
| K944859 | Orex Surgical DrapesKKX · Traditional | 02/28/1995SE |
| K944827 | Orex Surgeon's GownFYA · Traditional | 02/28/1995SE |
| K943034 | Orex Shoe CoversFXP · Traditional | 01/02/1995SE |
| K942228 | Orex O.R. TowelKKX · Traditional | 12/20/1994SE |
Questions and answers
When was Orex Medical Bedding cleared by the FDA?
Orex Medical Bedding (K944953) received a 510(k) decision of Substantially Equivalent on December 2, 1994, 56 days after the submission was received.
What is the product code of K944953?
The FDA product code is KME – Bedding, Disposable, Medical, a Class I (low risk) device regulated under 21 CFR 880.6060.