The following data is part of a premarket notification filed by Advanced Vision Technologies with the FDA for Avt Naturasoft.
Device ID | K121324 |
510k Number | K121324 |
Device Name: | AVT NATURASOFT |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | ADVANCED VISION TECHNOLOGIES 806 KIMBALL AVE Grand Junction, CO 81501 |
Contact | Martin Dalsing |
Correspondent | Martin Dalsing ADVANCED VISION TECHNOLOGIES 806 KIMBALL AVE 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 | 2012-05-02 |
Decision Date | 2012-08-23 |
Summary: | summary |