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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 K983143
Device Name MARK 5000 PHASED ARRAY SHOULDER COIL
Applicant
Usa Instruments, Inc.
1515 Danner Dr.
Aurora,  OH  44202
Applicant Contact RONY THOMAS
Correspondent
Usa Instruments, Inc.
1515 Danner Dr.
Aurora,  OH  44202
Correspondent Contact RONY THOMAS
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/08/1998
Decision Date 11/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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