The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Varian Multileaf Collimator.
| Device ID | K893464 |
| 510k Number | K893464 |
| Device Name: | VARIAN MULTILEAF COLLIMATOR |
| Classification | Block, Beam-shaping, Radiation Therapy |
| 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 | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-03 |
| Decision Date | 1989-08-10 |