The following data is part of a premarket notification filed by Hitesys S.p.a. with the FDA for Novac7.
| Device ID | K990209 |
| 510k Number | K990209 |
| Device Name: | NOVAC7 |
| Classification | Accelerator, Linear, Medical |
| Applicant | HITESYS S.P.A. 1592 HARBOR RD. Williamsburg, VA 23185 |
| Contact | Walter E Gundaker |
| Correspondent | Walter E Gundaker HITESYS S.P.A. 1592 HARBOR RD. Williamsburg, VA 23185 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-21 |
| Decision Date | 2000-06-22 |
| Summary: | summary |