Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K002724 |
Device Name |
NUMALINK |
Applicant |
NUMA, INC. |
10 NORTHERN BLVD., UNIT 12 |
AMHERST,
NH
03031
|
|
Applicant Contact |
LARRY SMITH |
Correspondent |
NUMA, INC. |
10 NORTHERN BLVD., UNIT 12 |
AMHERST,
NH
03031
|
|
Correspondent Contact |
LARRY SMITH |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/31/2000 |
Decision Date | 11/17/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|