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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name drum, opticokinetic
510(k) Number K822917
Device Name MODEL 5400 OPTOKINETIC STIMULATOR
Applicant
LIFE-TECH INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LIFE-TECH INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.1200
Classification Product Code
HOW  
Date Received10/01/1982
Decision Date 11/01/1982
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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