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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 K944779
Device Name CARBON LIGHTS HAND SURGERY TABLE
Applicant
Allen Medical Systems, Inc.
5198 Richmond Rd.
Bedford Heights,  OH  44146
Applicant Contact SUZANNE K RATZLOFF
Correspondent
Allen Medical Systems, Inc.
5198 Richmond Rd.
Bedford Heights,  OH  44146
Correspondent Contact SUZANNE K RATZLOFF
Regulation Number878.4950
Classification Product Code
FWZ  
Date Received09/27/1994
Decision Date 10/14/1994
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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