The following data is part of a premarket notification filed by Polystan A/s with the FDA for Safe Micro.
| Device ID | K953976 |
| 510k Number | K953976 |
| Device Name: | SAFE MICRO |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | POLYSTAN A/S WALGERHOLM 8 Vaerlose, DK Dk-3500 |
| Contact | Sverre Moe Haveland |
| Correspondent | Sverre Moe Haveland POLYSTAN A/S WALGERHOLM 8 Vaerlose, DK Dk-3500 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-23 |
| Decision Date | 1997-02-04 |