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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Non-Tilting, Powered
510(k) Number K903921
Device Name MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE
Applicant
Imt America, Inc.
402 W. Trade St.
Suite 200 Gateway Plaza
Charlotte,  NC  28202
Applicant Contact JOHN CARPENTER
Correspondent
Imt America, Inc.
402 W. Trade St.
Suite 200 Gateway Plaza
Charlotte,  NC  28202
Correspondent Contact JOHN CARPENTER
Regulation Number892.1980
Classification Product Code
IZZ  
Date Received08/24/1990
Decision Date 12/04/1990
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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