DU PONT MAMMOGRAPHY CASSETTE

Cassette, Radiographic Film

E.I. DUPONT DE NEMOURS & CO., INC.

The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Du Pont Mammography Cassette.

Pre-market Notification Details

Device IDK900620
510k NumberK900620
Device Name:DU PONT MAMMOGRAPHY CASSETTE
ClassificationCassette, Radiographic Film
Applicant E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington,  DE  19898
ContactKenneth L Woodlin
CorrespondentKenneth L Woodlin
E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington,  DE  19898
Product CodeIXA  
CFR Regulation Number892.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-08
Decision Date1990-02-26

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