The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Varian Clinacomp 100 Tissue Compensator.
| Device ID | K832216 |
| 510k Number | K832216 |
| Device Name: | VARIAN CLINACOMP 100 TISSUE COMPENSATOR |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-08 |
| Decision Date | 1983-09-12 |