Device Classification Name |
Saliva, Artificial
|
510(k) Number |
K061331 |
Device Name |
ORAL BALANCE LIQUID/ GEL |
Applicant |
LACLEDE, INC. |
2103 EAST UNIVERSITY DR. |
RANCHO DOMINQUEZ,
CA
90220
|
|
Applicant Contact |
MICHAEL A PELLICO |
Correspondent |
LACLEDE, INC. |
2103 EAST UNIVERSITY DR. |
RANCHO DOMINQUEZ,
CA
90220
|
|
Correspondent Contact |
MICHAEL A PELLICO |
Classification Product Code |
|
Date Received | 05/12/2006 |
Decision Date | 07/25/2006 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|