The following data is part of a premarket notification filed by Medical Instrumentation & Diagnostics Corp.(midco) with the FDA for Cass System.
| Device ID | K894263 |
| 510k Number | K894263 |
| Device Name: | CASS SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO) 806 SAGEBRUSH COURT SOUTHEAST Albuquerque, NM 87123 |
| Contact | Tyrone Hardy |
| Correspondent | Tyrone Hardy MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO) 806 SAGEBRUSH COURT SOUTHEAST Albuquerque, NM 87123 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-20 |
| Decision Date | 1989-09-01 |