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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screen, Intensifying, Radiographic
510(k) Number K845030
Device Name CRONEX SR342-QUANTA FAST DETAIL-INTENSI-SCREENS
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Dept.
Barley Mill Plz., P22-1170
Wilmington,  DE  19898
Applicant Contact SHERRILL
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Dept.
Barley Mill Plz., P22-1170
Wilmington,  DE  19898
Correspondent Contact SHERRILL
Regulation Number892.1960
Classification Product Code
EAM  
Date Received12/27/1984
Decision Date 02/26/1985
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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