The following data is part of a premarket notification filed by Insight Technologies Instruments, Llc. with the FDA for Keratome System.
| Device ID | K974243 |
| 510k Number | K974243 |
| Device Name: | KERATOME SYSTEM |
| Classification | Keratome, Battery-powered |
| Applicant | INSIGHT TECHNOLOGIES INSTRUMENTS, LLC. 16 HIGGINS DR. Milford, CT 06460 |
| Contact | Charles Vassallo |
| Correspondent | Charles Vassallo INSIGHT TECHNOLOGIES INSTRUMENTS, LLC. 16 HIGGINS DR. Milford, CT 06460 |
| Product Code | HMY |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-12 |
| Decision Date | 1998-01-20 |
| Summary: | summary |