The following data is part of a premarket notification filed by Permeable Technologies, Inc. with the FDA for Lifestyle Multivue-s (polymacon) Soft Hydrophilic Contact Lens.
Device ID | K942494 |
510k Number | K942494 |
Device Name: | LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LENS |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | PERMEABLE TECHNOLOGIES, INC. 712 GINESI DR. Morganville, NJ 07751 |
Contact | Martin S Knopf |
Correspondent | Martin S Knopf 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 | 1994-05-25 |
Decision Date | 1994-09-08 |