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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 K082100
Device Name ALLTECH ECHOSTAR 1.5 T MR SYSTEM
Applicant
ALLTECH MEDICAL SYSTEMS AMERICA, INC.
30825 AURORA ROAD
SUITE 100
SOLON,  OH  44139
Applicant Contact JOHN DURAJ
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/25/2008
Decision Date 08/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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