The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Cronex Quanta Rapid Sr397 Rare Earth Intens Screen.
| Device ID | K900448 |
| 510k Number | K900448 |
| Device Name: | CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN |
| Classification | Screen, Intensifying, Radiographic |
| 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 | EAM |
| CFR Regulation Number | 892.1960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-23 |
| Decision Date | 1990-02-16 |