Armboard Cver, Disposable
FDA 510(k) K782092 · Anago, Inc.
510(k) numberK782092
Submission
- Device name
- Armboard Cver, Disposable
- Applicant
- Anago, Inc.
Mchenry, IL, US - Received
- December 14, 1978
- Decision date
- January 10, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FSE – Table, Operating-Room, Manual
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4950
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FSE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K860503 | The Porex Retractor TableFSE · Traditional | Porex Medical | 03/13/1986SE |
| K843801 | Mason Equipment Organizer & AspenFSE · Traditional | Aspen Laboratories, Inc. | 10/25/1984SE |
| K840027 | Operating Room StandFSE · Traditional | Healthmate, Inc. | 02/04/1984SE |
| K831042 | Chemonucleolysis Table ExtensionFSE · Traditional | Orthopedic Systems, Inc. | 05/16/1983SE |
| K830339 | Imsi/Metripond Hand Operating TableFSE · Traditional | Intl. Management Services, Inc. | 04/12/1983SE |
| K822427 | Self-Contained Mobile Ophthal. Oper. .FSE · Traditional | Surgi-Quip Inc.U | 09/14/1982SE |
| K821924 | Table, Operating, Field 6530-00-709-8155FSE · Traditional | Emerson-Sack-Warner Corp. | 07/13/1982SE |
| K801382 | Disposable Surgical Head SupportFSE · Traditional | Innovative Surgical Products, Inc. | 06/26/1980SE |
| K780868 | Chest RollsFSE · Traditional | Devon Industries, Inc. | 08/14/1978SE |
| K780867 | Pad Holder KitFSE · Traditional | Devon Industries, Inc. | 08/14/1978SE |
More from Devon Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925659 | U.C.E.Z. Lens Cleaner KitOCT · Traditional | 09/17/1993SE |
| K930161 | Anago Spinal Anesthesia TrayCAZ · Traditional | 07/06/1993SEKD |
| K926590 | Anago Disposable Instant Cold PackIMD · Traditional | 05/26/1993SE |
| K926589 | Anago Warm PackIMD · Traditional | 05/26/1993SE |
| K926137 | Anago Fem-Cool/Fem-Cool PetiteIMD · Traditional | 05/26/1993SE |
| K920615 | Anago Continuous Epidural Anesthesia Tray/KitCAZ · Traditional | 03/20/1993SEKD |
| K915415 | Guardall ShieldLYU · Traditional | 10/15/1992SE |
| K913558 | Reliable Cone Style Face MaskFXX · Traditional | 11/07/1991SE |
| K905865 | Anti-For Surgical Face MaskFXX · Traditional | 03/06/1991SE |
| K905749 | Surgical Face MaskFXX · Traditional | 03/04/1991SE |
Questions and answers
When was Armboard Cver, Disposable cleared by the FDA?
Armboard Cver, Disposable (K782092) received a 510(k) decision of Substantially Equivalent on January 10, 1979, 27 days after the submission was received.
What is the product code of K782092?
The FDA product code is FSE – Table, Operating-Room, Manual, a Class I (low risk) device regulated under 21 CFR 878.4950.