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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Soft Lens Products
510(k) Number K000998
Device Name OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES
Applicant
Optisonic, Inc.
203 N. Wabash Ave. Suite 1200
Chicago,  IL  60601
Applicant Contact JOHN M SZABOCSIK
Correspondent
Optisonic, Inc.
203 N. Wabash Ave. Suite 1200
Chicago,  IL  60601
Correspondent Contact JOHN M SZABOCSIK
Regulation Number886.5928
Classification Product Code
LPN  
Date Received03/23/2000
Decision Date 06/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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