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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 K964820
Device Name MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A
Applicant
US ASIA INSTRUMENTS, INC.
675-B ALPHA DR.
HIGHLAND HEIGHTS,  OH  44143
Applicant Contact RONY THOMAS
Correspondent
US ASIA INSTRUMENTS, INC.
675-B ALPHA DR.
HIGHLAND HEIGHTS,  OH  44143
Correspondent Contact RONY THOMAS
Regulation Number892.1000
Classification Product Code
MOS  
Date Received12/02/1996
Decision Date 02/28/1997
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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