The following data is part of a premarket notification filed by Tangible Science Llc with the FDA for Tangible Hydrogel With Tangible Polymer (etafilcon A) Soft (hydrophilic) Daily Disposable Contact Lens.
Device ID | K172692 |
510k Number | K172692 |
Device Name: | Tangible Hydrogel With Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable 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 Lane 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 | 2017-09-06 |
Decision Date | 2017-12-13 |
Summary: | summary |