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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, Pneumatic
510(k) Number K863161
Device Name TABLE, OPERATING ROOM, HYDRAULIC
Applicant
Kamiya Tsusan Kaisha, Ltd.
C P O Box 1590
Tokyo, 100-91
Japan,  JP
Applicant Contact OSOZAWA
Correspondent
Kamiya Tsusan Kaisha, Ltd.
C P O Box 1590
Tokyo, 100-91
Japan,  JP
Correspondent Contact OSOZAWA
Regulation Number878.4960
Classification Product Code
FWW  
Date Received08/18/1986
Decision Date 09/05/1986
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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