Device Classification Name |
Plug, Punctum
|
510(k) Number |
K140026 |
Device Name |
COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST |
Applicant |
LACRIMEDICS, INC. |
2620 Williamson Pl NW Ste 113 |
Du Pont,
WA
98327
|
|
Applicant Contact |
REBECCA DUTTON |
Correspondent |
LACRIMEDICS, INC. |
2620 Williamson Pl NW Ste 113 |
Du Pont,
WA
98327
|
|
Correspondent Contact |
REBECCA DUTTON |
Classification Product Code |
|
Date Received | 01/06/2014 |
Decision Date | 06/03/2014 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|