The following data is part of a premarket notification filed by Computed Anatomy, Inc. with the FDA for Corneal Modeling System.
| Device ID | K862379 |
| 510k Number | K862379 |
| Device Name: | CORNEAL MODELING SYSTEM |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | COMPUTED ANATOMY, INC. 310 EAST 14TH ST. ROOM 232 SOUTH New York, NY 10003 |
| Contact | Martin Gersten |
| Correspondent | Martin Gersten COMPUTED ANATOMY, INC. 310 EAST 14TH ST. ROOM 232 SOUTH New York, NY 10003 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-24 |
| Decision Date | 1986-08-25 |