The following data is part of a premarket notification filed by Tangible Science Llc with the FDA for Tangible Hydrogel W/ Hydra-peg (etafilcon A) Soft (hydrophilic) Daily Wear Contact Lens.
| Device ID | K171125 |
| 510k Number | K171125 |
| Device Name: | Tangible Hydrogel W/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Tangible Science LLC 173 Jefferson Drive Menlo Park, CA 94025 |
| Contact | Vic Mccray |
| Correspondent | Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-17 |
| Decision Date | 2017-10-18 |
| Summary: | summary |