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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cassette, Radiographic Film
510(k) Number K941475
Device Name CRONEX REGULAR CASSETTE
Applicant
Dupont Medical Products
P.O. Box 80022, Bmp 22-1174
Wilmington,  DE  19880
Applicant Contact JEAN E BARTLETT
Correspondent
Dupont Medical Products
P.O. Box 80022, Bmp 22-1174
Wilmington,  DE  19880
Correspondent Contact JEAN E BARTLETT
Regulation Number892.1850
Classification Product Code
IXA  
Date Received03/28/1994
Decision Date 07/20/1994
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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