The following data is part of a premarket notification filed by Art Optical Contact Lens, Inc. with the FDA for Intelliwave3.
Device ID | K100221 |
510k Number | K100221 |
Device Name: | INTELLIWAVE3 |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | ART OPTICAL CONTACT LENS, INC. 806 KIMBALL AVENUE Grand Junction, CO 81501 |
Contact | Martin Dalsing |
Correspondent | Martin Dalsing ART OPTICAL CONTACT LENS, INC. 806 KIMBALL AVENUE Grand Junction, CO 81501 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-01-26 |
Decision Date | 2010-09-14 |
Summary: | summary |