Device Classification Name |
unit, operative dental
|
510(k) Number |
K973035 |
Device Name |
VIOLA II DENTAL CAMERA SYSTEM |
Applicant |
INNOVATIVE MEDICAL SYSTEMS, INC. |
55 STEAM WHISTLE DR. |
IVYLAND,
PA
18974
|
|
Applicant Contact |
KEVIN T SPURGEON |
Correspondent |
INNOVATIVE MEDICAL SYSTEMS, INC. |
55 STEAM WHISTLE DR. |
IVYLAND,
PA
18974
|
|
Correspondent Contact |
KEVIN T SPURGEON |
Regulation Number | 872.6640
|
Classification Product Code |
|
Date Received | 08/14/1997 |
Decision Date | 09/24/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|