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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 K943189
Device Name MEDRAD QWIK-FIX MRI DISPOSABLE KIT
Applicant
Medrad, Inc.
P.O. Box 780, Medrad Dr.
Off Rte. 910
Indianola,  PA  15051
Applicant Contact JAN BURTICK
Correspondent
Medrad, Inc.
P.O. Box 780, Medrad Dr.
Off Rte. 910
Indianola,  PA  15051
Correspondent Contact JAN BURTICK
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/05/1994
Decision Date 08/09/1995
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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