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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biomicroscope, slit-lamp, ac-powered
510(k) Number K900477
Device Name WOODLYN CLASSIC SLIT LAMP MODEL SMM
Applicant
WOODLYN, INC.
2920 MALMO DR.
ARLINGTON HEIGHTS,  IL  60005 -4726
Applicant Contact RONALD NIELSEN
Correspondent
WOODLYN, INC.
2920 MALMO DR.
ARLINGTON HEIGHTS,  IL  60005 -4726
Correspondent Contact RONALD NIELSEN
Regulation Number886.1850
Classification Product Code
HJO  
Date Received02/01/1990
Decision Date 02/21/1990
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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