| 510(k) Number |
K851841 |
| Device Name |
IMAX PERIOTIPS |
| Applicant |
| Stram Dental, Inc. |
| 655 Academy Dr. |
|
Northbrook,
IL
60062
|
|
| Applicant Contact |
AMRITA CHARI |
| Correspondent |
| Stram Dental, Inc. |
| 655 Academy Dr. |
|
Northbrook,
IL
60062
|
|
| Correspondent Contact |
AMRITA CHARI |
| Date Received | 04/26/1985 |
| Decision Date | 05/29/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|