The following data is part of a premarket notification filed by Paragon Vision Sciences with the FDA for Fluoroperm 151-ok, Paragon Hds 100-ok.
| Device ID | K010109 |
| 510k Number | K010109 |
| Device Name: | FLUOROPERM 151-OK, PARAGON HDS 100-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 | 2001-01-12 |
| Decision Date | 2001-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B22209 | K010109 | 000 |
| B22207 | K010109 | 000 |