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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, tomography, computed
510(k) Number K944983
Device Name MEDRAD COUNTERPOISE SYSTEM
Applicant
MEDRAD, INC.
271 KAPPA DR.
PITTSBURGH,  PA  15238 -2870
Applicant Contact JAN DOBSCHA
Correspondent
MEDRAD, INC.
271 KAPPA DR.
PITTSBURGH,  PA  15238 -2870
Correspondent Contact JAN DOBSCHA
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/11/1994
Decision Date 11/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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