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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K073310
Device Name OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL
Applicant
Hitachi Medical Corp.
1959 Summit Commerce Park
Twinsburg,  OH  44087
Applicant Contact DOUG THISTLEWAITE
Correspondent
Hitachi Medical Corp.
1959 Summit Commerce Park
Twinsburg,  OH  44087
Correspondent Contact DOUG THISTLEWAITE
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/23/2007
Decision Date 01/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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