SAFE-1
Oxygenator, Cardiopulmonary Bypass
POLYSTAN C/O VITALCOR, INC.
The following data is part of a premarket notification filed by Polystan C/o Vitalcor, Inc. with the FDA for Safe-1.
Pre-market Notification Details
| Device ID | K893704 |
| 510k Number | K893704 |
| Device Name: | SAFE-1 |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| 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 | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-18 |
| Decision Date | 1989-12-22 |
Trademark Results [SAFE-1]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SAFE-1 78358046 not registered Indifferent |
JT International Distributors, Inc. 0000-00-00 |
 SAFE-1 74456388 1893041 Dead/Cancelled |
SAFETY 1ST MEDICAL, INC. 1993-11-03 |
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