The following data is part of a premarket notification filed by Marco Ophthalmic, Inc. with the FDA for Marco Standard Keratometers.
| Device ID | K930444 |
| 510k Number | K930444 |
| Device Name: | MARCO STANDARD KERATOMETERS |
| Classification | Instrument, Measuring, Corneal Radius |
| Applicant | MARCO OPHTHALMIC, INC. 11825 CENTRAL PKWY. Jacksonville, FL 32224 |
| Contact | Wayne Starling |
| Correspondent | Wayne Starling MARCO OPHTHALMIC, INC. 11825 CENTRAL PKWY. Jacksonville, FL 32224 |
| Product Code | HJB |
| CFR Regulation Number | 886.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-26 |
| Decision Date | 1993-08-09 |