The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Varian C-series Clinacs (clinac 2300c/d).
| Device ID | K913119 |
| 510k Number | K913119 |
| Device Name: | VARIAN C-SERIES CLINACS (CLINAC 2300C/D) |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN ASSOC., INC. 3045 HANOVER ST. Palo Alto, CA 94304 -1129 |
| Contact | Charles H Will |
| Correspondent | Charles H Will VARIAN ASSOC., INC. 3045 HANOVER ST. Palo Alto, CA 94304 -1129 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-15 |
| Decision Date | 1991-11-07 |