Device Classification Name |
Material, Impression
|
510(k) Number |
K113263 |
Device Name |
ARGES IMAGING CONTRAST SPRAY |
Applicant |
ARGES IMAGING, INC |
129 NORTH HILL AVENUE |
PASADENA,
CA
91106
|
|
Applicant Contact |
Rebecca K Pine |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 872.3660
|
Classification Product Code |
|
Date Received | 11/04/2011 |
Decision Date | 11/14/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|