| Device Classification Name |
Agent, Polishing, Abrasive, Oral Cavity
|
| 510(k) Number |
K860843 |
| Device Name |
CHECK-UP PLAQUE FIGHTING GUM |
| Applicant |
| Minnetonka, Inc. |
| P.O. Box 1a |
|
Minnetonka,
MN
55343
|
|
| Applicant Contact |
JOHN L NEVEAUX |
| Correspondent |
| Minnetonka, Inc. |
| P.O. Box 1a |
|
Minnetonka,
MN
55343
|
|
| Correspondent Contact |
JOHN L NEVEAUX |
| Regulation Number | 872.6030 |
| Classification Product Code |
|
| Date Received | 03/06/1986 |
| Decision Date | 05/21/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|