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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 K941582
Device Name SUPERSENSOR MRI COIL
Applicant
Superconductor Technologies, Inc.
460 Ward Dr., Suite F
Santa Barbara,  CA  93111
Applicant Contact TIM JAMES
Correspondent
Superconductor Technologies, Inc.
460 Ward Dr., Suite F
Santa Barbara,  CA  93111
Correspondent Contact TIM JAMES
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/31/1994
Decision Date 12/23/1994
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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