The following data is part of a premarket notification filed by Permeable Technologies, Inc. with the FDA for Lifestyle 4-vue(tm) (polymacon) Hydrophilic Contact Lens.
Device ID | K950283 |
510k Number | K950283 |
Device Name: | LIFESTYLE 4-VUE(TM) (POLYMACON) HYDROPHILIC 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 | 1995-01-24 |
Decision Date | 1995-02-07 |