The following data is part of a premarket notification filed by Purilens, Inc. with the FDA for Purilens Saline Solution.
| Device ID | K002319 |
| 510k Number | K002319 |
| Device Name: | PURILENS SALINE SOLUTION |
| Classification | Accessories, Soft Lens Products |
| Applicant | PURILENS, INC. 3234 ELLA LN. New Port Richey, FL 34655 |
| Contact | Art Ward |
| Correspondent | Art Ward PURILENS, INC. 3234 ELLA LN. New Port Richey, FL 34655 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-31 |
| Decision Date | 2000-08-30 |