Fiberoptic Light Source W/Related Items
FDA 510(k) K822265 · Kelleher Corp.
510(k) numberK822265
Submission
- Device name
- Fiberoptic Light Source W/Related Items
- Applicant
- Kelleher Corp.
Mchenry, IL, US - Received
- July 29, 1982
- Decision date
- September 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EBA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070287 | PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500EBA · Traditional | Photonic Optische Gerate GmbH & Cokg | 02/12/2007SE |
| K923949 | Sylvan Dental Headlight SystemEBA · Traditional | Sylvan Medical Fiberoptics | 10/16/1992SE |
| K893458 | Fiberoptic Headlight SystemEBA · Traditional | Cuda Products Co. | 06/22/1989SE |
| K854646 | Vega Dental Operating LightEBA · Traditional | Alpine Dental Equipment Co. | 03/06/1986SE |
| K842515 | Surgical HeadlightEBA · Traditional | Good-Lite Co. | 08/02/1984SE |
| K842358 | IsolightEBA · Traditional | Planmeca USA, Inc. | 07/31/1984SE |
| K810117 | Halogen Headlight SystemEBA · Traditional | Colmed, Ltd. | 02/10/1981SE |
| K790807 | MetalitEBA · Traditional | Harry J. Bosworth Co. | 08/03/1979SE |
| K790806 | PorcelitEBA · Traditional | Harry J. Bosworth Co. | 08/03/1979SE |
More from Harry J. Bosworth Co.
| 510(k) | Device | Decision |
|---|---|---|
| K822618 | Emergency Tracheostomy Instrument SetLJW · Traditional | 01/28/1983SE |
| K822268 | Nagashima Ns-Iii ElectronystagmographGWN · Traditional | 01/28/1983SE |
| K823083 | Electrosurgical UnitGEI · Traditional | 12/07/1982SE |
| K823111 | Nystymograph AccessGNN · Traditional | 11/22/1982SE |
| K822252 | ENT Treatment UnitsETF · Traditional | 11/22/1982SE |
| K822272 | Head Mirrors W/Head Lamps & Head BandsHPQ · Traditional | 11/10/1982SE |
| K822017 | Tympanostomy Tubes & Various TypesETD · Traditional | 10/27/1982SE |
| K822257 | Various Types of Light Source HandlesEOQ · Traditional | 10/26/1982SE |
| K822259 | Laryngeal SpatulasEQH · Traditional | 10/22/1982SE |
| K822004 | Face ShieldsKNT · Traditional | 10/20/1982SE |
Questions and answers
When was Fiberoptic Light Source W/Related Items cleared by the FDA?
Fiberoptic Light Source W/Related Items (K822265) received a 510(k) decision of Substantially Equivalent on September 28, 1982, 61 days after the submission was received.
What is the product code of K822265?
The FDA product code is EBA – Light, Surgical Headlight, a Class I (low risk) device regulated under 21 CFR 872.4630.