The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Cronex Radiation Therapy Verification Cassette.
| Device ID | K953725 |
| 510k Number | K953725 |
| Device Name: | CRONEX RADIATION THERAPY VERIFICATION CASSETTE |
| Classification | Cassette, Radiographic Film |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. BUILDING 500, MAILBOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Jean E Bartlett |
| Correspondent | Jean E Bartlett E.I. DUPONT DE NEMOURS & CO., INC. BUILDING 500, MAILBOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-10 |
| Decision Date | 1995-09-06 |