The following data is part of a premarket notification filed by Polyvue Distribution, Inc. with the FDA for Polyvue 55 Single Vision, Toric And Multifocal Soft (hydrophilic) Contact Lens For Daily Wear.
| Device ID | K080794 |
| 510k Number | K080794 |
| Device Name: | POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | POLYVUE DISTRIBUTION, INC. 7077 MCADAMS LANE Felton, CA 95018 |
| Contact | Garold L Edwards |
| Correspondent | Garold L Edwards POLYVUE DISTRIBUTION, INC. 7077 MCADAMS LANE Felton, CA 95018 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-20 |
| Decision Date | 2008-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806392000794 | K080794 | 000 |
| 08806392000206 | K080794 | 000 |
| 08806392040097 | K080794 | 000 |
| 08806392040073 | K080794 | 000 |