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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K990359
Device Name KONICA DIRECT DIGITIZER, MODEL DD-341
Applicant
KONICA CORP.
THE CHRYSLER BUILDING
405 LEXINGTON AVENUE
NEW YORK,  NY  10174
Applicant Contact RUSSELL D MUNVES
Correspondent
KONICA CORP.
THE CHRYSLER BUILDING
405 LEXINGTON AVENUE
NEW YORK,  NY  10174
Correspondent Contact RUSSELL D MUNVES
Regulation Number892.1680
Classification Product Code
MQB  
Date Received02/05/1999
Decision Date 08/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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