Device Classification Name |
Osmolality Of Tears
|
510(k) Number |
K083184 |
Device Name |
TEARLAB OSMOLARITY SYSTEM |
Applicant |
OCUSENSE, INC. |
1835 MARKET ST., 29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Applicant Contact |
JANICE M HOGAN |
Correspondent |
OCUSENSE, INC. |
1835 MARKET ST., 29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Correspondent Contact |
JANICE M HOGAN |
Regulation Number | 862.1540
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/28/2008 |
Decision Date | 05/14/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00731484
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|