Device Classification Name |
Saliva, Artificial
|
510(k) Number |
K991938 |
Device Name |
CAPHOSOL ARTIFICIAL SALIVA |
Applicant |
INPHARMA A.S. |
P.O. BOX 809, 27 SOUTH ST. |
NORTHBOROUGH,
MA
01532
|
|
Applicant Contact |
BRUCE R MANNING |
Correspondent |
INPHARMA A.S. |
P.O. BOX 809, 27 SOUTH ST. |
NORTHBOROUGH,
MA
01532
|
|
Correspondent Contact |
BRUCE R MANNING |
Classification Product Code |
|
Date Received | 06/09/1999 |
Decision Date | 08/10/1999 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|