The following data is part of a premarket notification filed by Western Laboratories Corp. with the FDA for Model 90 Pressure/conductivity/temp Test.
| Device ID | K801303 |
| 510k Number | K801303 |
| Device Name: | MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | WESTERN LABORATORIES CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-03 |
| Decision Date | 1980-07-28 |