The following data is part of a premarket notification filed by Bausch & Lomb with the FDA for Ngdi (next Generation Diagnostic Instrument).
| Device ID | K040913 |
| 510k Number | K040913 |
| Device Name: | NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) |
| Classification | Device, Analysis, Anterior Segment |
| Applicant | BAUSCH & LOMB 180 VIA VERDE DRIVE San Dimas, CA 91773 |
| Contact | David Thomas |
| Correspondent | Derwyn Reuber INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MXK |
| Subsequent Product Code | HJO |
| Subsequent Product Code | NCF |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-04-08 |
| Decision Date | 2004-07-23 |
| Summary: | summary |