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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K943440
Device Name PROFILE 7000 C-SPINE COIL
Applicant
Us Asia Instruments, Inc.
675-B Alpha Dr.
Highland Heights,  OH  44143
Applicant Contact ELIZABETH M RICHARDS
Correspondent
Us Asia Instruments, Inc.
675-B Alpha Dr.
Highland Heights,  OH  44143
Correspondent Contact ELIZABETH M RICHARDS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/18/1994
Decision Date 10/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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