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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Projector, Ophthalmic
510(k) Number K890992
Device Name WOODLYN OPHTHALMIC PROJECTOR
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 Number886.1680
Classification Product Code
HOS  
Date Received02/27/1989
Decision Date 05/17/1989
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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