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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Measuring, Lens, Ac-Powered
510(k) Number K920861
Device Name WOODLYN CLASSIC LENSMETER
Applicant
Woodlyn, Inc.
2920 Malmo Dr.
Arlington Heights,  IL  60005
Applicant Contact RONALD NIELSON
Correspondent
Woodlyn, Inc.
2920 Malmo Dr.
Arlington Heights,  IL  60005
Correspondent Contact RONALD NIELSON
Regulation Number886.1425
Classification Product Code
HLM  
Date Received02/25/1992
Decision Date 07/30/1992
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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