The following data is part of a premarket notification filed by Paragon Vision Sciences with the FDA for Paragon Lens Care.
| Device ID | K974635 |
| 510k Number | K974635 |
| Device Name: | PARAGON LENS CARE |
| 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 | 1997-12-12 |
| Decision Date | 1998-02-04 |
| Summary: | summary |