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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K993893
Device Name MEDX INTECAM INTERFACE
Applicant
Medx, Inc.
3456 N. Ridge Ave. #100
Arlington Heights,  IL  60004
Applicant Contact FLOYD ROWAN
Correspondent
Medx, Inc.
3456 N. Ridge Ave. #100
Arlington Heights,  IL  60004
Correspondent Contact FLOYD ROWAN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received11/16/1999
Decision Date 02/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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