The following data is part of a premarket notification filed by Paragon Vision Sciences with the FDA for Hds Hi 1.54.
| Device ID | K082799 |
| 510k Number | K082799 |
| Device Name: | HDS HI 1.54 |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | PARAGON VISION SCIENCES 947 EAST IMPALA AVE. Mesa, AZ 85204 |
| Contact | William Meyers |
| Correspondent | William 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 | 2008-09-23 |
| Decision Date | 2009-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B22216 | K082799 | 000 |