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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K951180
Device Name ESSTECH SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
Applicant
Szabocsik and Assoc.
203 N. Wabash Ave.
Suite 1200
Chicago,  IL  60601
Applicant Contact JOHN M SZABOCISK
Correspondent
Szabocsik and Assoc.
203 N. Wabash Ave.
Suite 1200
Chicago,  IL  60601
Correspondent Contact JOHN M SZABOCISK
Regulation Number886.5925
Classification Product Code
LPL  
Date Received03/16/1995
Decision Date 04/07/1995
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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