The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Cronex Compact Mammography Cassette.
| Device ID | K895335 |
| 510k Number | K895335 |
| Device Name: | CRONEX COMPACT 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 Woodlin |
| Correspondent | Kenneth 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 | 1989-08-31 |
| Decision Date | 1990-02-16 |