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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Operating-Room, Ac-Powered
510(k) Number K864295
Device Name DR.500O OPERATING TABLE
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 Number878.4960
Classification Product Code
FQO  
Date Received10/31/1986
Decision Date 11/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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