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 |