The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Hospal Biospal Scu/cavh Kit.
| Device ID | K841152 |
| 510k Number | K841152 |
| Device Name: | HOSPAL BIOSPAL SCU/CAVH KIT |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | HOSPAL MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-19 |
| Decision Date | 1984-07-06 |