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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 K935369
Device Name FAST SPIN ECHO (FSE)
Applicant
Resonex, Inc.
47911 Westinghouse Dr.
Fremont,  CA  94539
Applicant Contact E. BRUCE FLOYD
Correspondent
Resonex, Inc.
47911 Westinghouse Dr.
Fremont,  CA  94539
Correspondent Contact E. BRUCE FLOYD
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/04/1993
Decision Date 03/21/1994
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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