The following data is part of a premarket notification filed by Specialty Tint with the FDA for Specialty Tint Soft Contact Lens.
Device ID | K003079 |
510k Number | K003079 |
Device Name: | SPECIALTY TINT SOFT CONTACT LENS |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | SPECIALTY TINT 1325 PROGRESS DR. Front Royal, VA 22630 |
Contact | Robert Breece |
Correspondent | Robert Breece SPECIALTY TINT 1325 PROGRESS DR. Front Royal, VA 22630 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-10-03 |
Decision Date | 2000-11-21 |