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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, Tilting
510(k) Number K903422
Device Name MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE
Applicant
Imt America, Inc.
402 W. Trade St.
Suite 200 Gateway Plz.
Charlotte,  NC  28202
Applicant Contact JOHN CARPENTER
Correspondent
Imt America, Inc.
402 W. Trade St.
Suite 200 Gateway Plz.
Charlotte,  NC  28202
Correspondent Contact JOHN CARPENTER
Regulation Number892.1980
Classification Product Code
IXR  
Date Received07/31/1990
Decision Date 09/04/1990
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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