The following data is part of a premarket notification filed by Nof Corp. with the FDA for Lipidure Rewetting Drops.
| Device ID | K000975 |
| 510k Number | K000975 |
| Device Name: | LIPIDURE REWETTING DROPS |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | NOF CORP. 269A BALLARDVALE ST. Wilmington, MA 01887 |
| Contact | Ann Kurowski |
| Correspondent | Ann Kurowski NOF CORP. 269A BALLARDVALE ST. Wilmington, MA 01887 |
| Product Code | MRC |
| CFR Regulation Number | 886.5918 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-27 |
| Decision Date | 2000-09-25 |