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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 K841766
Device Name WOODLYN CLASSIC TRIAL LENS SET
Applicant
WOODLYN, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
WOODLYN, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.1405
Classification Product Code
HPC  
Date Received04/27/1984
Decision Date 06/01/1984
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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