Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K071614 |
Device Name |
FIDUCIAL MARKERS |
Applicant |
CIVCO |
1401 8TH ST. SE |
ORANGE CITY,
IA
51041 -0320
|
|
Applicant Contact |
JIM LEONG |
Correspondent |
CIVCO |
1401 8TH ST. SE |
ORANGE CITY,
IA
51041 -0320
|
|
Correspondent Contact |
JIM LEONG |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 06/13/2007 |
Decision Date | 09/11/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|