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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Lens, Trial, Ophthalmic
510(k) Number K900478
Device Name WOODLYN FULL APERTURE TRIAL LENS SET
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 Number886.1405
Classification Product Code
HPC  
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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