Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K862645 |
Device Name |
CLINAC (R) C SERIES (400C, 600C, 2100C, 2500C) |
Applicant |
VARIAN ASSOC., INC. |
611 HANSEN WAY |
P.O. BOX 10800 |
PALO ALTO,
CA
94303
|
|
Applicant Contact |
RICHARD M LEVY |
Correspondent |
VARIAN ASSOC., INC. |
611 HANSEN WAY |
P.O. BOX 10800 |
PALO ALTO,
CA
94303
|
|
Correspondent Contact |
RICHARD M LEVY |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 07/11/1986 |
Decision Date | 10/03/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|