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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 K953724
Device Name CRONEX RADIATION THERAPY CASSETTE
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Glasgow Business Community
P.O. Box 6101, B500, Box 514
Newark,  DE  19714
Applicant Contact JEAN E BARTLETT
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Glasgow Business Community
P.O. Box 6101, B500, Box 514
Newark,  DE  19714
Correspondent Contact JEAN E BARTLETT
Regulation Number892.1850
Classification Product Code
IXA  
Date Received08/10/1995
Decision Date 09/06/1995
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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