The following data is part of a premarket notification filed by Novabay Pharmaceuticals, Inc with the FDA for Icase Contact Lens Case.
| Device ID | K143351 |
| 510k Number | K143351 |
| Device Name: | ICase Contact Lens Case |
| Classification | Case, Contact Lens |
| Applicant | Novabay Pharmaceuticals, Inc 5980 Horton St., Suite 550 Emeryville, CA 94608 |
| Contact | Charles Francavilla |
| Correspondent | Ellen M Beucler Foresight Regulatory Strategies, Inc 187 Ballardvale Street Suite 180 Wilmington, MA 01887 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-24 |
| Decision Date | 2015-04-29 |
| Summary: | summary |