The following data is part of a premarket notification filed by Medical Instruments Corporation Mic Ag with the FDA for Lot 440.
| Device ID | K950087 |
| 510k Number | K950087 |
| Device Name: | LOT 440 |
| Classification | Electrode, Ph, Stomach |
| Applicant | MEDICAL INSTRUMENTS CORPORATION MIC AG FRIEDHOFPLATZ 16, POB 706 CH-4502 Solothurn, CH Ch-4502 |
| Contact | John C Matherly |
| Correspondent | John C Matherly MEDICAL INSTRUMENTS CORPORATION MIC AG FRIEDHOFPLATZ 16, POB 706 CH-4502 Solothurn, CH Ch-4502 |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-10 |
| Decision Date | 1996-02-06 |