The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Varian Clinac 1800s.
Device ID | K882326 |
510k Number | K882326 |
Device Name: | VARIAN CLINAC 1800S |
Classification | Accelerator, Linear, Medical |
Applicant | VARIAN ASSOC., INC. 611 HANSEN WAY P.O. BOX 10800 Palo Alto, CA 94303 |
Contact | Milton D Siegel |
Correspondent | Milton D Siegel VARIAN ASSOC., INC. 611 HANSEN WAY P.O. BOX 10800 Palo Alto, CA 94303 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-06 |
Decision Date | 1988-09-19 |