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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, Tomography, Computed
510(k) Number K002005
Device Name BOLUSPRO ULTRA
Applicant
MARCONI MEDICAL SYSTEMS, INC.
5595 MINER RD.
HIGHLAND HEIGHTS,  OH  44143
Applicant Contact ROBERT L TUROCY
Correspondent
MARCONI MEDICAL SYSTEMS, INC.
5595 MINER RD.
HIGHLAND HEIGHTS,  OH  44143
Correspondent Contact ROBERT L TUROCY
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/03/2000
Decision Date 09/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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