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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 K052621
Device Name 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
Applicant
USA INSTRUMENTS, INC.
1515 DANNER DR.
AURORA,  OH  44202
Applicant Contact ROBERT B SMITH
Correspondent
USA INSTRUMENTS, INC.
1515 DANNER DR.
AURORA,  OH  44202
Correspondent Contact ROBERT B SMITH
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/23/2005
Decision Date 10/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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