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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K913012
Device Name DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES
Applicant
Eigen
P.O. Box 848
Nevada City,  CA  95959
Applicant Contact MARK A HOFFMAN
Correspondent
Eigen
P.O. Box 848
Nevada City,  CA  95959
Correspondent Contact MARK A HOFFMAN
Regulation Number892.1650
Classification Product Code
JAA  
Date Received07/08/1991
Decision Date 09/23/1991
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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