Mason Equipment Organizer & Aspen
FDA 510(k) K843801 · Aspen Laboratories, Inc.
510(k) numberK843801
Submission
- Device name
- Mason Equipment Organizer & Aspen
- Applicant
- Aspen Laboratories, Inc.
Englewood, CO, US - Received
- September 27, 1984
- Decision date
- October 25, 1984
- 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 |
| 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 |
| K782092 | Armboard Cver, DisposableFSE · Traditional | Anago, Inc. | 01/10/1979SE |
| 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 |
|---|---|---|
| K981220 | System 7500 Abc Electrosurgical UnitGEI · Traditional | 04/21/1998SE |
| K963088 | Sheath, Electrosurgical PencilGEI · Traditional | 09/13/1996SE |
| K955834 | System 6500 Abc Electrosurgical UnitGEI · Traditional | 07/11/1996SE |
| K960296 | 4000 EtmGEI · Traditional | 02/20/1996SE |
| K953081 | Beamer PlusGEI · Traditional | 10/30/1995SE |
| K953007 | Excalibur Plus Electrosurgical UnitGEI · Traditional | 08/21/1995SE |
| K946104 | Smokievac Electrosurgical PencilGEI · Traditional | 04/03/1995SE |
| K944012 | Electrosurgical Flexible Electrode In-Line Suction CoagulatorGEI · Traditional | 12/21/1994SE |
| K924960 | Excalibur Electrosurgical UnitGEI · Traditional | 04/16/1993SE |
| K913213 | Single Use Lee ElectrodeHGI · Traditional | 02/13/1992SE |
Questions and answers
When was Mason Equipment Organizer & Aspen cleared by the FDA?
Mason Equipment Organizer & Aspen (K843801) received a 510(k) decision of Substantially Equivalent on October 25, 1984, 28 days after the submission was received.
What is the product code of K843801?
The FDA product code is FSE – Table, Operating-Room, Manual, a Class I (low risk) device regulated under 21 CFR 878.4950.