Device Classification Name |
system, x-ray, extraoral source, digital
|
510(k) Number |
K122643 |
Device Name |
VANTAGE MODEL V5000, V5100, V5000C, V5100C |
Applicant |
MIDMARK CORP. |
675 HEATHROW DRIVE |
LINCOLNSHIRE,
IL
60069
|
|
Applicant Contact |
MARK GREENWOOD |
Correspondent |
MIDMARK CORP. |
675 HEATHROW DRIVE |
LINCOLNSHIRE,
IL
60069
|
|
Correspondent Contact |
MARK GREENWOOD |
Regulation Number | 872.1800
|
Classification Product Code |
|
Date Received | 08/29/2012 |
Decision Date | 01/07/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|