The following data is part of a premarket notification filed by Circon Video with the FDA for Metal Halide Light Source, Models Mv-9088-t, Mv-9088.
| Device ID | K012265 |
| 510k Number | K012265 |
| Device Name: | METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 |
| Classification | Light Source, Fiberoptic, Routine |
| Applicant | CIRCON VIDEO 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Contact | Wayne B Sterner |
| Correspondent | Wayne B Sterner CIRCON VIDEO 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Product Code | FCW |
| Subsequent Product Code | FCR |
| Subsequent Product Code | FFS |
| Subsequent Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-19 |
| Decision Date | 2001-10-17 |