Ophtec Rust Ring Remover
FDA 510(k) K834354 · Jedmed Instrument Co.
510(k) numberK834354
Submission
- Device name
- Ophtec Rust Ring Remover
- Applicant
- Jedmed Instrument Co.
Mchenry, IL, US - Received
- December 13, 1983
- Decision date
- March 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HOG – Burr, Corneal, Battery-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4070
- Specialty
- Ophthalmic
Other 510(k)s with product code HOG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962989 | Amoils Epithelial ScrubberHOG · Traditional | S. Percy Amoils | 01/09/1997SE |
| K960261 | Pallikaris BrushHOG · Traditional | Alcon Laboratories, Inc. | 03/11/1996SE |
| K950520 | Burr, Corneal, Battery-PoweredHOG · Traditional | Aaron Medical Industries | 05/02/1995SE |
| K883785 | Gy-Ro SafeHOG · Traditional | Gy-Ro Industry, Inc. | 01/05/1989SE |
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| K021750 | Lid Chain Eyelid WeightsMML · Traditional | 01/27/2003SE |
| K954184 | Jed-Light Fiberoptic Light SourceEQH · Traditional | 11/13/1995SE |
| K944032 | Video Scope System (Laryngoscope)ENZ · Traditional | 09/15/1995SE |
| K953457 | Jedmed Spectrum ENT CabinetETF · Traditional | 08/11/1995SE |
| K950925 | Jedmed Laryngeal ScopeEOQ · Traditional | 08/11/1995SE |
| K950785 | Hortmann Airmatic Air Caloric StimulatorKHH · Traditional | 06/28/1995SE |
| K950078 | Microflow Irrigation SystemKMA · Traditional | 06/21/1995SE |
| K944671 | Video Scope System (Nasopharyngoscope {Flexible or Rigid})EOB · Traditional | 02/07/1995SE |
Questions and answers
When was Ophtec Rust Ring Remover cleared by the FDA?
Ophtec Rust Ring Remover (K834354) received a 510(k) decision of Substantially Equivalent on March 19, 1984, 97 days after the submission was received.
What is the product code of K834354?
The FDA product code is HOG – Burr, Corneal, Battery-Powered, a Class I (low risk) device regulated under 21 CFR 886.4070.