The following data is part of a premarket notification filed by Advocacy International, Ltd. with the FDA for Polystan Heart Lung Machine Sys.
| Device ID | K813034 |
| 510k Number | K813034 |
| Device Name: | POLYSTAN HEART LUNG MACHINE SYS |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | ADVOCACY INTERNATIONAL, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-28 |
| Decision Date | 1981-11-27 |