The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Biospal 3000 S.
| Device ID | K832645 |
| 510k Number | K832645 |
| Device Name: | BIOSPAL 3000 S |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | HOSPAL MEDICAL 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 | 1983-08-05 |
| Decision Date | 1983-09-20 |