The following data is part of a premarket notification filed by Allergan Humphrey with the FDA for Allergan Humphrey Auto-refractor, Models 525 & 540.
| Device ID | K871611 |
| 510k Number | K871611 |
| Device Name: | ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540 |
| Classification | Refractometer, Ophthalmic |
| Applicant | ALLERGAN HUMPHREY 3081 TEAGARDEN ST. San Leandro, CA 94577 |
| Contact | Dean A Knight |
| Correspondent | Dean A Knight ALLERGAN HUMPHREY 3081 TEAGARDEN ST. San Leandro, CA 94577 |
| Product Code | HKO |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-10 |
| Decision Date | 1987-05-18 |