The following data is part of a premarket notification filed by Sight Sciences, Inc. with the FDA for Visco 360 Viscosurgical System.
Device ID | K171905 |
510k Number | K171905 |
Device Name: | VISCO 360 Viscosurgical System |
Classification | Pump, Infusion, Ophthalmic |
Applicant | Sight Sciences, Inc. 3000 Sand Hill Road, Building 3 Suite 105 Menlo Park, CA 94025 |
Contact | Anne-marie Ripley |
Correspondent | Anne-marie Ripley Sight Sciences, Inc. 3000 Sand Hill Road, Building 3 Suite 105 Menlo Park, CA 94025 |
Product Code | MRH |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-06-26 |
Decision Date | 2017-07-27 |
Summary: | summary |