510(k) K852424
- Device
- ACUFEX COMPARATIVE SURGICAL KERATOMETER
- Applicant
- ACUFEX MICROSURGICAL, INC.
- 510(k) number
- K852424
- Product code
- HJB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-09-11
- Date received
- 1985-06-07
- Regulation
- 886.1450
- Classification name
- Instrument, Measuring, Corneal Radius
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM RICHARDS
- Address
- 575 University Ave. Norwood MA US 02062 02062
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 |
| K924779 | BURTON KERATOMETER - MODLE 2040 | R.H. Burton Co. | 1993-04-05 |
| K864369 | LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER | Heidelberg Instruments | 1986-12-15 |
| K864037 | KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER | Kera Corp. | 1986-11-13 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases