The following data is part of a premarket notification filed by Wesley Jessen Corp. with the FDA for Precision Uv (vasurfilcon A).
Device ID | K982988 |
510k Number | K982988 |
Device Name: | PRECISION UV (VASURFILCON A) |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | WESLEY JESSEN CORP. 333 E. HOWARD AVE. Des Plaines, IL 60018 -5903 |
Contact | Joseph Foos |
Correspondent | Joseph Foos WESLEY JESSEN CORP. 333 E. HOWARD AVE. Des Plaines, IL 60018 -5903 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-26 |
Decision Date | 1999-01-06 |
Summary: | summary |