The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Comparative Surgical Keratometer.
| Device ID | K852424 |
| 510k Number | K852424 |
| Device Name: | ACUFEX COMPARATIVE SURGICAL KERATOMETER |
| Classification | Instrument, Measuring, Corneal Radius |
| Applicant | ACUFEX MICROSURGICAL, INC. 575 UNIVERSITY AVE. Norwood, MA 02062 |
| Contact | William Richards |
| Correspondent | William Richards ACUFEX MICROSURGICAL, INC. 575 UNIVERSITY AVE. Norwood, MA 02062 |
| Product Code | HJB |
| CFR Regulation Number | 886.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-07 |
| Decision Date | 1985-09-11 |