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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 K935381
Device Name KAPS POSITIONING ARM
Applicant
Andronic Devices, Ltd.
140-13120 Vanier Pl.
Richmond,B.C. Canada,  CA V6V2J2
Applicant Contact ROBERT MACNEIL
Correspondent
Andronic Devices, Ltd.
140-13120 Vanier Pl.
Richmond,B.C. Canada,  CA V6V2J2
Correspondent Contact ROBERT MACNEIL
Regulation Number878.4950
Classification Product Code
FWZ  
Date Received11/08/1993
Decision Date 04/15/1994
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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