The following data is part of a premarket notification filed by Futuristic Design Assoc. with the FDA for Flosi Rigid Gas Permeable Contact Lens.
| Device ID | K974636 |
| 510k Number | K974636 |
| Device Name: | FLOSI RIGID GAS PERMEABLE CONTACT LENS |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | FUTURISTIC DESIGN ASSOC. ONE AVALON RD. P.O. BOX 1009 Mount Vernon, OH 43050 |
| Contact | William Platt |
| Correspondent | William Platt FUTURISTIC DESIGN ASSOC. ONE AVALON RD. P.O. BOX 1009 Mount Vernon, OH 43050 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-12 |
| Decision Date | 1998-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858174006034 | K974636 | 000 |