The following data is part of a premarket notification filed by Strieter Clinical Research Laboratories, Inc. with the FDA for Contaclair Multi-purpose Contact Lens Solution.
Device ID | K994021 |
510k Number | K994021 |
Device Name: | CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION |
Classification | Accessories, Solution, Ultrasonic Cleaners For Lenses |
Applicant | STRIETER CLINICAL RESEARCH LABORATORIES, INC. 222 VANDALIA ST. Collinsville, IL 62234 |
Contact | James F Strieter |
Correspondent | James F Strieter STRIETER CLINICAL RESEARCH LABORATORIES, INC. 222 VANDALIA ST. Collinsville, IL 62234 |
Product Code | LYL |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-26 |
Decision Date | 2000-02-22 |