The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Dupont Cronex Portable Grid Cassette.
Device ID | K941518 |
510k Number | K941518 |
Device Name: | DUPONT CRONEX PORTABLE GRID 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 | 1994-03-30 |
Decision Date | 1994-06-06 |