Fiberoptic Headlight System
FDA 510(k) K893458 · Cuda Products Co.
510(k) numberK893458
Submission
- Device name
- Fiberoptic Headlight System
- Applicant
- Cuda Products Co.
Jacksonville, FL, US - Received
- May 2, 1989
- Decision date
- June 22, 1989
- 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 |
| 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 |
| K822265 | Fiberoptic Light Source W/Related ItemsEBA · Traditional | Kelleher Corp. | 09/28/1982SE |
| 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 |
|---|---|---|
| K983277 | Lightsource or Illuminator Model I-100HBI · Traditional | 12/16/1998SE |
| K981962 | Cuda Products Corp. Model M300 (M-300) LightsourceFSS · Traditional | 08/18/1998SE |
| K981469 | CERMAX300 LightsourceFSS · Traditional | 07/09/1998SE |
| K980350 | Video Camera/Lightsource Combination Unit Model VCL-150GCJ · Traditional | 04/28/1998SE |
| K980166 | Lightsource or IlluminatorHET · Traditional | 04/01/1998SE |
| K961074 | Lightsource or IlluminatorFSS · Traditional | 04/30/1996SE |
| K951019 | Intraoral Video Scope and Window TubeEIA · Traditional | 05/10/1995SE |
| K943731 | Video OtoscopeERA · Traditional | 10/11/1994SE |
| K935818 | EndoscopeGDB · Traditional | 07/13/1994SE |
| K933369 | Cuda Products Corp. LightsourcesFCW · Traditional | 01/03/1994SE |
Questions and answers
When was Fiberoptic Headlight System cleared by the FDA?
Fiberoptic Headlight System (K893458) received a 510(k) decision of Substantially Equivalent on June 22, 1989, 51 days after the submission was received.
What is the product code of K893458?
The FDA product code is EBA – Light, Surgical Headlight, a Class I (low risk) device regulated under 21 CFR 872.4630.