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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 K031172
Device Name SPIRIT III TOTALSENSE CARDIAC COIL
Applicant
USA INSTRUMENTS, INC.
1515 DANNER DR.
AURORA,  OH  44202
Applicant Contact CHRISTIE SHUMAKER
Correspondent
USA INSTRUMENTS, INC.
1515 DANNER DR.
AURORA,  OH  44202
Correspondent Contact CHRISTIE SHUMAKER
Regulation Number892.1000
Classification Product Code
MOS  
Date Received04/14/2003
Decision Date 05/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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