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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
Applicant Contact RONALD NIELSEN
Correspondent
Woodlyn, Inc.
2920 Malmo Dr.
Arlington Heights,  IL  60005
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
Predetermined Change
Control Plan Authorized		 No
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