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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 K900919
Device Name MODIFIED HITACHI MRP-20 MAGNETIC RESONANCE DIAGNOS
Applicant
Summit World Trade Corp.
70 W. St.Sbro St.
Hudson,  OH  44236
Applicant Contact WILLIAM J BISHOP
Correspondent
Summit World Trade Corp.
70 W. St.Sbro St.
Hudson,  OH  44236
Correspondent Contact WILLIAM J BISHOP
Regulation Number892.1000
Classification Product Code
LNH  
Date Received02/20/1990
Decision Date 05/14/1990
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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