Device Classification Name |
Pump, Infusion, Ophthalmic
|
510(k) Number |
K171905 |
Device Name |
VISCO 360 Viscosurgical System |
Applicant |
Sight Sciences, Inc. |
3000 Sand Hill Road, Building 3 |
Suite 105 |
Menlo Park,
CA
94025
|
|
Applicant Contact |
Anne-Marie Ripley |
Correspondent |
Sight Sciences, Inc. |
3000 Sand Hill Road, Building 3 |
Suite 105 |
Menlo Park,
CA
94025
|
|
Correspondent Contact |
Anne-Marie Ripley |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 06/26/2017 |
Decision Date | 07/27/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|