| Device Classification Name |
System, Image Processing, Radiological
|
| 510(k) Number |
K110430 |
| Device Name |
DOLPHIN IMAGING |
| Applicant |
| Patterson Dental Supply, Inc. |
| 1031 Mendota Heights Rd. |
|
St. Paul,
MN
55120
|
|
| Applicant Contact |
DAWN LI |
| Correspondent |
| Patterson Dental Supply, Inc. |
| 1031 Mendota Heights Rd. |
|
St. Paul,
MN
55120
|
|
| Correspondent Contact |
DAWN LI |
| Regulation Number | 892.2050 |
| Classification Product Code |
|
| Date Received | 02/14/2011 |
| Decision Date | 05/11/2011 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|