Device Classification Name |
Saliva, Artificial
|
510(k) Number |
K822971 |
Device Name |
SALIVA SUBSTITUTE |
Applicant |
ROXANE LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ROXANE LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Classification Product Code |
|
Date Received | 10/08/1982 |
Decision Date | 11/16/1982 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|