The following data is part of a premarket notification filed by Advanced Vision Research, Inc. with the FDA for Theratears Contact Lens Comfort Drops.
| Device ID | K032481 |
| 510k Number | K032481 |
| Device Name: | THERATEARS CONTACT LENS COMFORT DROPS |
| Classification | Accessories, Soft Lens Products |
| Applicant | ADVANCED VISION RESEARCH, INC. 269A BALLARDVALE STREET Wilmington, MA 01887 |
| Contact | Beverley D Venuti |
| Correspondent | Beverley D Venuti ADVANCED VISION RESEARCH, 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 | 2003-08-12 |
| Decision Date | 2003-11-04 |
| Summary: | summary |