The following data is part of a premarket notification filed by Paragon Vision Sciences with the FDA for Paragon Lens Vial.
| Device ID | K993487 |
| 510k Number | K993487 |
| Device Name: | PARAGON LENS VIAL |
| Classification | Case, Contact Lens |
| Applicant | PARAGON VISION SCIENCES 947 EAST IMPALA AVE. Mesa, AZ 85204 |
| Contact | William E Meyers |
| Correspondent | William E Meyers PARAGON VISION SCIENCES 947 EAST IMPALA AVE. Mesa, AZ 85204 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-15 |
| Decision Date | 1999-12-22 |
| Summary: | summary |