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 |