The following data is part of a premarket notification filed by Polystan C/o Vitalcor, Inc. with the FDA for Polystan Heater-cooler Unit.
| Device ID | K893940 |
| 510k Number | K893940 |
| Device Name: | POLYSTAN HEATER-COOLER UNIT |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | POLYSTAN C/O VITALCOR, INC. 8, WALGERHOLM DK-3500 VAERLOSE Denmark, DK |
| Contact | Henning S Larsen |
| Correspondent | Henning S Larsen POLYSTAN C/O VITALCOR, INC. 8, WALGERHOLM DK-3500 VAERLOSE Denmark, DK |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-31 |
| Decision Date | 1990-01-18 |