The following data is part of a premarket notification filed by Hawken Industries with the FDA for Horizon Epikeratome Disposable Microkeratome System.
| Device ID | K052891 |
| 510k Number | K052891 |
| Device Name: | HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM |
| Classification | Keratome, Ac-powered |
| Applicant | HAWKEN INDUSTRIES 377 ROUTE 17 S Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers HAWKEN INDUSTRIES 377 ROUTE 17 S Hasbrouck Heights, NJ 07604 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-13 |
| Decision Date | 2006-03-23 |
| Summary: | summary |