The following data is part of a premarket notification filed by Medical Instrumentation & Diagnostics Corp.(midco) with the FDA for Cass System (modification).
| Device ID | K961484 |
| 510k Number | K961484 |
| Device Name: | CASS SYSTEM (MODIFICATION) |
| Classification | Accelerator, Linear, Medical |
| Applicant | MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO) 5995 MIRA MESA BLVD. SUITE B San Diego, CA 92121 |
| Contact | Tyrone L Hardy |
| Correspondent | Tyrone L Hardy MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO) 5995 MIRA MESA BLVD. SUITE B San Diego, CA 92121 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-29 |
| Decision Date | 1996-11-07 |
| Summary: | summary |