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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 K023982
Device Name LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE WRIST 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 Received12/02/2002
Decision Date 02/21/2003
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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