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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Products, Contact Lens Care, Rigid Gas Permeable
510(k) Number K052074
Device Name JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING,
Applicant
Szabocsik and Associates
203 N.Wabash, Suite 1200
Chicago,  IL  60601
Applicant Contact JOHN M SZABOCSIK
Correspondent
Szabocsik and Associates
203 N.Wabash, Suite 1200
Chicago,  IL  60601
Correspondent Contact JOHN M SZABOCSIK
Regulation Number886.5918
Classification Product Code
MRC  
Date Received08/01/2005
Decision Date 09/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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