| 510(k) Number |
K896826 |
| Device Name |
SULTAN PERIO-SELECT IRRIGATION SYSTEM |
| Applicant |
| Sultan Chemists, Inc. |
| 7-B Old Colony Dr. |
|
Westford,
MA
01886
|
|
| Applicant Contact |
R MARSHALL,PHD |
| Correspondent |
| Sultan Chemists, Inc. |
| 7-B Old Colony Dr. |
|
Westford,
MA
01886
|
|
| Correspondent Contact |
R MARSHALL,PHD |
| Date Received | 12/04/1989 |
| Decision Date | 03/02/1990 |
| Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|