The following data is part of a premarket notification filed by Paragon Vision Sciences with the FDA for Fluroperm 60-ok, Paragon Hds-ok.
| Device ID | K000224 |
| 510k Number | K000224 |
| Device Name: | FLUROPERM 60-OK, PARAGON HDS-OK |
| Classification | Lens, Contact (orthokeratology) |
| 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 | MUW |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-24 |
| Decision Date | 2000-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B22208 | K000224 | 000 |
| B22205 | K000224 | 000 |