The following data is part of a premarket notification filed by Paragon Vision Sciences with the FDA for Fluoroperm 92, 60, 30 And 151 And Paragon Hds, Hds 100 And Thin Rigid Gas Permeable Contact Lenses.
| Device ID | K070637 |
| 510k Number | K070637 |
| Device Name: | FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES |
| 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 | 2007-03-07 |
| Decision Date | 2007-05-01 |