| Device Classification Name |
Floss, Dental
|
| 510(k) Number |
K942690 |
| Device Name |
RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE |
| Applicant |
| Ranir/Dcp Corp. |
| 4701 E. Paris SE |
|
Grand Rapids,
MI
49512
|
|
| Applicant Contact |
ANNE M ARMSTRONG |
| Correspondent |
| Ranir/Dcp Corp. |
| 4701 E. Paris SE |
|
Grand Rapids,
MI
49512
|
|
| Correspondent Contact |
ANNE M ARMSTRONG |
| Regulation Number | 872.6390 |
| Classification Product Code |
|
| Date Received | 06/07/1994 |
| Decision Date | 04/27/1995 |
| 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
|
|
|