The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Cotral I W/4.5 L/hr. Ultrafiltrat. Capa.
| Device ID | K822386 |
| 510k Number | K822386 |
| Device Name: | COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA |
| Classification | System, Dialysate Delivery, Sealed |
| Applicant | HOSPAL MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FII |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-09 |
| Decision Date | 1982-10-06 |