The following data is part of a premarket notification filed by Permeable Technologies, Inc. with the FDA for Lifestyle 55 (methafilcon A) Soft Hydrophilic Contact Lens.
| Device ID | K945981 |
| 510k Number | K945981 |
| Device Name: | LIFESTYLE 55 (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | PERMEABLE TECHNOLOGIES, INC. 712 GINESI DR. Morganville, NJ 07751 |
| Contact | Mark K Tyson |
| Correspondent | Mark K Tyson PERMEABLE TECHNOLOGIES, INC. 712 GINESI DR. Morganville, NJ 07751 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-08 |
| Decision Date | 1995-02-07 |