Device Classification Name |
saliva, artificial
|
510(k) Number |
K181134 |
Device Name |
G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray |
Applicant |
Sunstar Americas Inc |
301 E. Central Road |
Schaumburg,
IL
60195
|
|
Applicant Contact |
Liz Bastian |
Correspondent |
Sunstar Americas Inc |
301 E. Central Road |
Schaumburg,
IL
60195
|
|
Correspondent Contact |
Liz Bastian |
Classification Product Code |
|
Date Received | 04/30/2018 |
Decision Date | 07/13/2018 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|