Pad Holder Kit
FDA 510(k) K780867 · Devon Industries, Inc.
510(k) numberK780867
Submission
- Device name
- Pad Holder Kit
- Applicant
- Devon Industries, Inc.
Mchenry, IL, US - Received
- May 30, 1978
- Decision date
- August 14, 1978
- 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 |
| K782092 | Armboard Cver, DisposableFSE · Traditional | Anago, Inc. | 01/10/1979SE |
| K780868 | Chest RollsFSE · Traditional | Devon Industries, Inc. | 08/14/1978SE |
More from Devon Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K961993 | Birthday Kit (Obstetrical Delivery Kit)MLS · Traditional | 07/03/1996SE |
| K954015 | Abg Point Lok Needle Protection DeviceCBT · Traditional | 11/20/1995SE |
| K946289 | Devons Point Lok Needle Protection DeviceFMI · Traditional | 07/10/1995SE |
| K945197 | The Sharps Collection and Disposal SystemMMK · Traditional | 12/02/1994SE |
| K944114 | Phlebotomy Unit Sharps a GatorFMI · Traditional | 12/02/1994SE |
| K943892 | Point of Use Sharps a GatorFMI · Traditional | 12/02/1994SE |
| K945485 | Abg Needle ProtectionCBT · Traditional | 11/29/1994SE |
| K932998 | Easy-OnGES · Traditional | 08/18/1993SE |
| K912824 | Devon Sponge Counter BagsLWH · Traditional | 08/26/1991SE |
| K894170 | Devon Disposable Head Positioner CoverKME · Traditional | 09/07/1989SE |
Questions and answers
When was Pad Holder Kit cleared by the FDA?
Pad Holder Kit (K780867) received a 510(k) decision of Substantially Equivalent on August 14, 1978, 76 days after the submission was received.
What is the product code of K780867?
The FDA product code is FSE – Table, Operating-Room, Manual, a Class I (low risk) device regulated under 21 CFR 878.4950.