The following data is part of a premarket notification filed by Polystan C/o Vitalcor, Inc. with the FDA for Polystan Heart-lung Machine System.
| Device ID | K894657 |
| 510k Number | K894657 |
| Device Name: | POLYSTAN HEART-LUNG MACHINE SYSTEM |
| Classification | Test Reagents For Phenothiazine |
| Applicant | POLYSTAN C/O VITALCOR, INC. 8, WALGERHOLM DK-3500 VAERLOSE Denmark, DK |
| Contact | Henning Larsen |
| Correspondent | Henning Larsen POLYSTAN C/O VITALCOR, INC. 8, WALGERHOLM DK-3500 VAERLOSE Denmark, DK |
| Product Code | DJQ |
| CFR Regulation Number | 862.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1990-03-28 |