The following data is part of a premarket notification filed by Paragon Vision Sciences with the FDA for Fluoroperm 151 (paflufocon D) And Paragon Hds 100 (paflufocon D) Rigid Gas Permeable Contact Lenses.
| Device ID | K052983 |
| 510k Number | K052983 |
| Device Name: | FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) 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 | 2005-10-24 |
| Decision Date | 2006-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B22204 | K052983 | 000 |