510(k) K883785
- Device
- GY-RO SAFE
- Applicant
- GY-RO INDUSTRY, INC.
- 510(k) number
- K883785
- Product code
- HOG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-01-05
- Date received
- 1988-09-07
- Regulation
- 886.4070
- Classification name
- Burr, Corneal, Battery-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WM. N WEST
- Address
- Box 87794 Houston TX US 77287 77287
FDA Registration Numbers#
- 2242450
- 1720747
- 8043867
- 1836161
- 8040278
- 1643817
- 3015972897
- 9611665
- 8030607
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HOG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962989 | AMOILS EPITHELIAL SCRUBBER | S. Percy Amoils | 1997-01-09 |
| K960261 | PALLIKARIS BRUSH | Alcon Laboratories, Inc. | 1996-03-11 |
| K950520 | BURR, CORNEAL, BATTERY-POWERED | Aaron Medical Industries | 1995-05-02 |
| K834354 | OPHTEC RUST RING REMOVER | Jedmed Instrument Co. | 1984-03-19 |
Legacy Summary#
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FDA Review#
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