The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Opti-free Express Multi-action Cleaning And Rewetting Drop.
| Device ID | K984573 |
| 510k Number | K984573 |
| Device Name: | OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP |
| Classification | Accessories, Soft Lens Products |
| Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Contact | Ralph H Larsen |
| Correspondent | Ralph H Larsen ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-23 |
| Decision Date | 1999-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00300650192378 | K984573 | 000 |
| 00300650192316 | K984573 | 000 |
| 00300650192293 | K984573 | 000 |
| 00300650192101 | K984573 | 000 |
| 00300650192057 | K984573 | 000 |