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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Eye, Artificial, Non-Custom
510(k) Number K923167
Device Name THE NISSEL ARTIFICIAL EYE
Applicant
Nissel , Ltd.
151 N. Michigan Ave.
Suite 2114
Chicago,  IL  60601
Applicant Contact JOHN SZABOCSIK
Correspondent
Nissel , Ltd.
151 N. Michigan Ave.
Suite 2114
Chicago,  IL  60601
Correspondent Contact JOHN SZABOCSIK
Regulation Number886.3200
Classification Product Code
HQH  
Date Received06/29/1992
Decision Date 09/02/1992
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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