Device Classification Name |
saliva, artificial
|
510(k) Number |
K152201 |
Device Name |
MedActive Oral Gel and Spray |
Applicant |
MedActive Oral Pharmaceuticals, LLC. |
1900 Gunn Highway |
Odessa,
FL
33556
|
|
Applicant Contact |
Brian Walker |
Correspondent |
MedActive Oral Pharmaceuticals, LLC. |
1900 Gunn Highway |
Odessa,
FL
33556
|
|
Correspondent Contact |
Brian Walker |
Classification Product Code |
|
Date Received | 08/06/2015 |
Decision Date | 12/30/2015 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|