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 |