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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name chair, ophthalmic, ac-powered
510(k) Number K842045
Device Name WOODLYN CLASSIC EXAM. CHAIR
Applicant
WOODLYN, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
WOODLYN, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.1140
Classification Product Code
HME  
Date Received05/21/1984
Decision Date 06/19/1984
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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