510(k) K924779
- Device
- BURTON KERATOMETER - MODLE 2040
- Applicant
- R.H. BURTON CO.
- 510(k) number
- K924779
- Product code
- HJB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-04-05
- Date received
- 1992-09-23
- Regulation
- 886.1450
- Classification name
- Instrument, Measuring, Corneal Radius
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEVIN M LOYCHIK
- Address
- 3965 Brookham Dr. P.O. Box 68 Grove City OH US 43123 43123
FDA Registration Numbers#
- 3009465247
- 8040382
- 1646747
- 3004571672
- 3003951061
- 3011137372
- 9612297
- 1045379
- 8040381
- 8043368
- 3011898560
- 3008618183
- 2529846
- 3013503739
- 3010041511
- 8040278
- 9614661
- 1836161
- 3008729548
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HJB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K930444 | MARCO STANDARD KERATOMETERS | Marco Ophthalmic, Inc. | 1993-08-09 |
| K864369 | LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER | Heidelberg Instruments | 1986-12-15 |
| K864037 | KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER | Kera Corp. | 1986-11-13 |
| K852424 | ACUFEX COMPARATIVE SURGICAL KERATOMETER | Acufex Microsurgical, Inc. | 1985-09-11 |
Legacy Summary#
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FDA Review#
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