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.
Device ID | K900620 |
510k Number | K900620 |
Device Name: | DU PONT MAMMOGRAPHY CASSETTE |
Classification | Cassette, Radiographic Film |
Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
Contact | Kenneth L Woodlin |
Correspondent | Kenneth L Woodlin E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
Product Code | IXA |
CFR Regulation Number | 892.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-08 |
Decision Date | 1990-02-26 |