The following data is part of a premarket notification filed by Biomatrix, Inc. with the FDA for Hylashield Cl.
| Device ID | K994170 |
| 510k Number | K994170 |
| Device Name: | HYLASHIELD CL |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | BIOMATRIX, INC. 65 RAILROAD AVE. Ridgefield, NJ 07657 |
| Contact | Nadine M Qashu |
| Correspondent | Nadine M Qashu BIOMATRIX, INC. 65 RAILROAD AVE. Ridgefield, NJ 07657 |
| Product Code | MRC |
| CFR Regulation Number | 886.5918 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-10 |
| Decision Date | 2000-03-02 |
| Summary: | summary |