Burr, Corneal, Battery-Powered
FDA 510(k) K950520 · Aaron Medical Industries
510(k) numberK950520
Submission
- Device name
- Burr, Corneal, Battery-Powered
- Applicant
- Aaron Medical Industries
St. Petersburg, FL, US - Received
- February 6, 1995
- Decision date
- May 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K883785 | Gy-Ro SafeHOG · Traditional | Gy-Ro Industry, Inc. | 01/05/1989SE |
| K834354 | Ophtec Rust Ring RemoverHOG · Traditional | Jedmed Instrument Co. | 03/19/1984SE |
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Questions and answers
When was Burr, Corneal, Battery-Powered cleared by the FDA?
Burr, Corneal, Battery-Powered (K950520) received a 510(k) decision of Substantially Equivalent on May 2, 1995, 85 days after the submission was received.
What is the product code of K950520?
The FDA product code is HOG – Burr, Corneal, Battery-Powered, a Class I (low risk) device regulated under 21 CFR 886.4070.