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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K905833
Device Name MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY
Applicant
SUMMIT WORLD TRADE CORP.
70 WEST STREETSBRO ST.
HUDSON,  OH  44236
Applicant Contact ROBERT H MCCARTHY
Correspondent
SUMMIT WORLD TRADE CORP.
70 WEST STREETSBRO ST.
HUDSON,  OH  44236
Correspondent Contact ROBERT H MCCARTHY
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/31/1990
Decision Date 02/25/1991
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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