The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Millennium Mlc -120.
Device ID | K990085 |
510k Number | K990085 |
Device Name: | MILLENNIUM MLC -120 |
Classification | Accelerator, Linear, Medical |
Applicant | VARIAN ASSOC., INC. 3045 HANOVER ST. MAIL STOP H-055 Palo Alto, CA 94304 -1129 |
Contact | Linda S Nash |
Correspondent | Linda S Nash VARIAN ASSOC., INC. 3045 HANOVER ST. MAIL STOP H-055 Palo Alto, CA 94304 -1129 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-01-11 |
Decision Date | 1999-02-08 |
Summary: | summary |