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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 K864574
Device Name MAC 150E OPTHALMIC CHAIR
Applicant
Koken Mfg Company, Inc.
1631 M.L. King Dr.
St. Louis,  MO  63106
Applicant Contact MASAYA KOSAKA
Correspondent
Koken Mfg Company, Inc.
1631 M.L. King Dr.
St. Louis,  MO  63106
Correspondent Contact MASAYA KOSAKA
Regulation Number886.1140
Classification Product Code
HME  
Date Received11/20/1986
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
Predetermined Change
Control Plan Authorized		 No
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