The following data is part of a premarket notification filed by Permeable Technologies, Inc. with the FDA for Lifestyle 4-vue (polymacon) Hydrophilic Multifocal Contact Lens For Daily Wear.
| Device ID | K963001 |
| 510k Number | K963001 |
| Device Name: | LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | PERMEABLE TECHNOLOGIES, INC. 6 SHADOWBROOK DR. Colts Neck, NJ 07722 |
| Contact | Martin S Knopf |
| Correspondent | Martin S Knopf PERMEABLE TECHNOLOGIES, INC. 6 SHADOWBROOK DR. Colts Neck, NJ 07722 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-02 |
| Decision Date | 1997-03-11 |