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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 K964854
Device Name MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL
Applicant
MEDRAD, INC.
271 KAPPA DR.
PITTSBURGH,  PA  15238 -2870
Applicant Contact RODNEY J RYLANDS
Correspondent
MEDRAD, INC.
271 KAPPA DR.
PITTSBURGH,  PA  15238 -2870
Correspondent Contact RODNEY J RYLANDS
Regulation Number892.1000
Classification Product Code
MOS  
Date Received12/03/1996
Decision Date 02/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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