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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K923356
Device Name MEDX ROTATIONAL GANTRY SYSTEM
Applicant
Bfi- Medical Waste Systems
925 A.E.C. Dr.
Wood Dale,  IL  60191
Applicant Contact ROBERT MOSS
Correspondent
Bfi- Medical Waste Systems
925 A.E.C. Dr.
Wood Dale,  IL  60191
Correspondent Contact ROBERT MOSS
Regulation Number892.1100
Classification Product Code
IYX  
Date Received07/08/1992
Decision Date 09/21/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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