510(k) K962989
- Device
- AMOILS EPITHELIAL SCRUBBER
- Applicant
- S. PERCY AMOILS
- 510(k) number
- K962989
- Product code
- HOG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-01-09
- Date received
- 1996-08-01
- Regulation
- 886.4070
- Classification name
- Burr, Corneal, Battery-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD O WOOD, ESQ.
- Address
- 333 W. Wacker Dr. Suite 2600 Chicago IL US 60606 60606
FDA Registration Numbers#
- 2242450
- 1720747
- 8043867
- 1836161
- 8040278
- 1643817
- 3015972897
- 9611665
- 8030607
Source Documents#
Other 510(k) Records For Product Code HOG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960261 | PALLIKARIS BRUSH | Alcon Laboratories, Inc. | 1996-03-11 |
| K950520 | BURR, CORNEAL, BATTERY-POWERED | Aaron Medical Industries | 1995-05-02 |
| K883785 | GY-RO SAFE | Gy-Ro Industry, Inc. | 1989-01-05 |
| K834354 | OPHTEC RUST RING REMOVER | Jedmed Instrument Co. | 1984-03-19 |
Legacy Summary#
summary
FDA Review#
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