Cleared Traditional

CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION

K994021 · Strieter Clinical Research Laboratories, Inc. · Ophthalmic

Feb 2000

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K994021 is an FDA 510(k) clearance for the CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION, a Accessories, Solution, Ultrasonic Cleaners For Lenses (Class II — Special Controls, product code LYL), submitted by Strieter Clinical Research Laboratories, Inc. (Collinsville, US). The FDA issued a Cleared decision on February 22, 2000, 88 days after receiving the submission on November 26, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number	K994021 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 1999
Decision Date	February 22, 2000
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement