The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Independent Jaw Mode Option For Varian Clinac 4/10.
Device ID | K844424 |
510k Number | K844424 |
Device Name: | INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10 |
Classification | System, Therapeutic, X-ray |
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 | JAD |
CFR Regulation Number | 892.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-15 |
Decision Date | 1985-02-21 |