The following data is part of a premarket notification filed by Permeable Technologies, Inc. with the FDA for Lifestyle 55 (ocufilcon D) Hydrophilic Contact Lens Lifestyle Frequency 55 (ocufilcon D) Ghydrophilic Contact Lens.
| Device ID | K951893 |
| 510k Number | K951893 |
| Device Name: | LIFESTYLE 55 (OCUFILCON D) HYDROPHILIC CONTACT LENS LIFESTYLE FREQUENCY 55 (OCUFILCON D) GHYDROPHILIC CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | PERMEABLE TECHNOLOGIES, INC. 712 GOMESI DR. Morganville, NJ 07751 |
| Contact | Mark K Tyson |
| Correspondent | Mark K Tyson PERMEABLE TECHNOLOGIES, INC. 712 GOMESI 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 | 1995-04-24 |
| Decision Date | 1995-11-17 |