The following data is part of a premarket notification filed by Sight Sciences, Inc. with the FDA for Viscoelastic Injector.
| Device ID | K143205 |
| 510k Number | K143205 |
| Device Name: | Viscoelastic Injector |
| Classification | Pump, Infusion, Ophthalmic |
| Applicant | Sight Sciences, Inc. 3000 Sand Hill Road, Building 3 Suite 105 Menlo Park, CA 94025 |
| Contact | Paul Badawl |
| Correspondent | Judy Gordon ClinReg Consulting Services, Inc. 733 Bolsana Drive Laguna Beach, CA 92651 |
| Product Code | MRH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-07 |
| Decision Date | 2014-12-05 |
| Summary: | summary |