Device Classification Name |
Saliva, Artificial
|
510(k) Number |
K120552 |
Device Name |
AIR LIFT/XEROSTOM ARTIFICIAL SALIVA |
Applicant |
BIOCOSMETICS LABORATORIES |
57 LAZY BROOK RD |
MONROE,
CT
06468
|
|
Applicant Contact |
Ray Kelly |
Correspondent |
BIOCOSMETICS LABORATORIES |
57 LAZY BROOK RD |
MONROE,
CT
06468
|
|
Correspondent Contact |
Ray Kelly |
Classification Product Code |
|
Date Received | 02/23/2012 |
Decision Date | 06/06/2012 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|