The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Cronex Regular Cassette.
| Device ID | K941475 |
| 510k Number | K941475 |
| Device Name: | CRONEX REGULAR CASSETTE |
| Classification | Cassette, Radiographic Film |
| Applicant | DUPONT MEDICAL PRODUCTS P.O. BOX 80022, BMP 22-1174 Wilmington, DE 19880 -0022 |
| Contact | Jean E Bartlett |
| Correspondent | Jean E Bartlett DUPONT MEDICAL PRODUCTS P.O. BOX 80022, BMP 22-1174 Wilmington, DE 19880 -0022 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-28 |
| Decision Date | 1994-07-20 |