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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Solution, Ultrasonic Cleaners For Lenses
510(k) Number K994021
Device Name CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
Applicant
Strieter Clinical Research Laboratories, Inc.
222 Vandalia St.
Collinsville,  IL  62234
Applicant Contact JAMES F STRIETER
Correspondent
Strieter Clinical Research Laboratories, Inc.
222 Vandalia St.
Collinsville,  IL  62234
Correspondent Contact JAMES F STRIETER
Regulation Number886.5928
Classification Product Code
LYL  
Date Received11/26/1999
Decision Date 02/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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