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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K896739
Device Name KONICA KFDR-S
Applicant
Konica Medical Corp.
757 Third Ave.
New York,  NY  10017
Applicant Contact JORDAN B BIERMAN
Correspondent
Konica Medical Corp.
757 Third Ave.
New York,  NY  10017
Correspondent Contact JORDAN B BIERMAN
Regulation Number892.2030
Classification Product Code
LMA  
Date Received11/30/1989
Decision Date 04/30/1990
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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