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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 NORTH MICHIGAN AVE.
SUITE 2114
CHICAGO,  IL  60601
Applicant Contact JOHN SZABOCSIK
Correspondent
NISSEL LTD.
151 NORTH 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
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