The following data is part of a premarket notification filed by Wilsa, Inc. with the FDA for Sereine Extra Strength Daily Cleaner.
| Device ID | K011561 |
| 510k Number | K011561 |
| Device Name: | SEREINE EXTRA STRENGTH DAILY CLEANER |
| Classification | Accessories, Soft Lens Products |
| Applicant | WILSA, INC. 2172 SOUTH JASON ST. Denver, CO 80223 |
| Contact | Sally Cook |
| Correspondent | Sally Cook WILSA, INC. 2172 SOUTH JASON ST. Denver, CO 80223 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-21 |
| Decision Date | 2001-11-20 |
| Summary: | summary |