The following data is part of a premarket notification filed by Medical Instrumentation & Diagnostics Corp.(midco) with the FDA for Modified Cass System.
| Device ID | K902488 |
| 510k Number | K902488 |
| Device Name: | MODIFIED CASS SYSTEM |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO) 806 SAGEBRUSH COURT SOUTHEAST Albuquerque, NM 87123 |
| Contact | Hardy, M.d. |
| Correspondent | Hardy, M.d. MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO) 806 SAGEBRUSH COURT SOUTHEAST Albuquerque, NM 87123 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-30 |
| Decision Date | 1990-12-07 |