The following data is part of a premarket notification filed by R.h. Burton Co. with the FDA for Burton Auto Refractor/keratometer - Model Bark-8.
| Device ID | K924778 |
| 510k Number | K924778 |
| Device Name: | BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 |
| Classification | Refractometer, Ophthalmic |
| Applicant | R.H. BURTON CO. 3965 BROOKHAM DR. P.O. BOX 68 Grove City, OH 43123 |
| Contact | Kevin M Loychik |
| Correspondent | Kevin M Loychik R.H. BURTON CO. 3965 BROOKHAM DR. P.O. BOX 68 Grove City, OH 43123 |
| Product Code | HKO |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-23 |
| Decision Date | 1993-04-05 |