SAFE MINI
Oxygenator, Cardiopulmonary Bypass
POLYSTAN A/S
The following data is part of a premarket notification filed by Polystan A/s with the FDA for Safe Mini.
Pre-market Notification Details
| Device ID | K980974 |
| 510k Number | K980974 |
| Device Name: | SAFE MINI |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | POLYSTAN A/S WALGERHOLM 8 Vaerlose, DK Dk-3500 |
| Contact | Thomas Andersen |
| Correspondent | Thomas Andersen 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 | 1998-03-16 |
| Decision Date | 2000-10-13 |
Trademark Results [SAFE MINI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SAFE MINI 86099653 not registered Dead/Abandoned |
Top Rollshutters Inc. 2013-10-23 |
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