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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Refractor, Manual, Non-Powered, Including Phoropter
510(k) Number K874900
Device Name WOODLYN CLASSIC REFRACTOR, PHOROPTOR
Applicant
Woodlyn, Inc.
2920 Malmo Dr.
Arlington Heights,  IL  60005
Applicant Contact RONAL NIELSEN
Correspondent
Woodlyn, Inc.
2920 Malmo Dr.
Arlington Heights,  IL  60005
Correspondent Contact RONAL NIELSEN
Regulation Number886.1770
Classification Product Code
HKN  
Date Received12/01/1987
Decision Date 12/23/1987
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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