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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Operating Room Accessories Table Tray
510(k) Number K860446
Device Name C ARM SURGICAL TABLE
Applicant
Medi-Mech, Inc.
P.O. Box 976
1802 W. Second St.
The Dalles,  OR  97058
Applicant Contact BRUCE SCHWARTZ
Correspondent
Medi-Mech, Inc.
P.O. Box 976
1802 W. Second St.
The Dalles,  OR  97058
Correspondent Contact BRUCE SCHWARTZ
Regulation Number878.4950
Classification Product Code
FWZ  
Date Received02/04/1986
Decision Date 03/10/1986
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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