The following data is part of a premarket notification filed by Adventures In Color Technology, Ltd. with the FDA for Adventure Tints, Color Enhanced Tinted Soft Contact Lens.
Device ID | K984098 |
510k Number | K984098 |
Device Name: | ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | ADVENTURES IN COLOR TECHNOLOGY, LTD. 623 GLACIER DR. Grand Junction, CO 81503 |
Contact | Martin Dalsing |
Correspondent | Martin Dalsing ADVENTURES IN COLOR TECHNOLOGY, LTD. 623 GLACIER DR. Grand Junction, CO 81503 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-17 |
Decision Date | 1999-05-10 |
Summary: | summary |