The following data is part of a premarket notification filed by Arent Fox with the FDA for Ocusystem(art).
| Device ID | K945583 |
| 510k Number | K945583 |
| Device Name: | OCUSYSTEM(ART) |
| Classification | Unit, Phacofragmentation |
| Applicant | ARENT FOX 1050 CONNECTICUT AVE. N.W. Washington, DC 20036 |
| Contact | Wayne H Matelski |
| Correspondent | Wayne H Matelski ARENT FOX 1050 CONNECTICUT AVE. N.W. Washington, DC 20036 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-02-13 |