The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Refresh Optive Lens Comfort Rewetting Drops.
| Device ID | K083812 |
| 510k Number | K083812 |
| Device Name: | REFRESH OPTIVE LENS COMFORT REWETTING DROPS |
| Classification | Accessories, Soft Lens Products |
| Applicant | ALLERGAN, INC. 269A BALLARDVALE STREET Wilmington, MA 01887 |
| Contact | Beverley D Venuti |
| Correspondent | Beverley D Venuti ALLERGAN, INC. 269A BALLARDVALE STREET Wilmington, MA 01887 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-22 |
| Decision Date | 2009-07-09 |
| Summary: | summary |