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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 K884598
Device Name SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200
Applicant
Shimadzu Precision Instruments, Inc.
20410 Earl St.
Torrance,  CA  90503
Applicant Contact HARRY DEMINT
Correspondent
Shimadzu Precision Instruments, Inc.
20410 Earl St.
Torrance,  CA  90503
Correspondent Contact HARRY DEMINT
Regulation Number892.1650
Classification Product Code
JAA  
Date Received11/03/1988
Decision Date 04/20/1989
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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