The following data is part of a premarket notification filed by Paragon Vision Sciences with the FDA for Fluoroperm 30 Paragon Hds Fluoroperm 60 Paragon Hds 100 Fluoroperm 92 Fluoroperm 151 Paragon Thin.
| Device ID | K120996 |
| 510k Number | K120996 |
| Device Name: | FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN |
| Classification | Lens, Contact (other Material) - Daily |
| 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 | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-02 |
| Decision Date | 2012-06-28 |
| Summary: | summary |