The following data is part of a premarket notification filed by American Optisurgical, Inc. with the FDA for Horizon Phacoemulsification System, Model Hzn-2030.
| Device ID | K020527 |
| 510k Number | K020527 |
| Device Name: | HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 |
| Classification | Unit, Phacofragmentation |
| Applicant | AMERICAN OPTISURGICAL, INC. 25501 ARCTIC OCEAN Lake Forest, CA 92630 |
| Contact | Nanette Canepa |
| Correspondent | Nanette Canepa AMERICAN OPTISURGICAL, INC. 25501 ARCTIC OCEAN Lake Forest, CA 92630 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-19 |
| Decision Date | 2002-07-09 |
| Summary: | summary |