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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 K864494
Device Name MODEL 6500 OPTHALMIC CHAIR
Applicant
KOKEN MFG COMPANY, INC.
P.O. BOX 265
ST. LOUIS,  MO  63166
Applicant Contact MASAYA KOSAKA
Correspondent
KOKEN MFG COMPANY, INC.
P.O. BOX 265
ST. LOUIS,  MO  63166
Correspondent Contact MASAYA KOSAKA
Regulation Number886.1140
Classification Product Code
HME  
Date Received11/14/1986
Decision Date 12/15/1986
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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