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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 K942186
Device Name ESSTECH PS ASPHERIC
Applicant
Szabocsik and Assoc.
405 N. Wabash Ave.,
Suite 1402
Chicago,  IL  60611
Applicant Contact JOHN M SZABOCSIK, PH.D
Correspondent
Szabocsik and Assoc.
405 N. Wabash Ave.,
Suite 1402
Chicago,  IL  60611
Correspondent Contact JOHN M SZABOCSIK, PH.D
Regulation Number886.5925
Classification Product Code
LPL  
Date Received05/04/1994
Decision Date 07/28/1994
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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