The following data is part of a premarket notification filed by Althin Medical Ab An Affiliate Of Baxter Intl with the FDA for Seraflo Arterial And Venous Bloodline Sets.
| Device ID | K913526 |
| 510k Number | K913526 |
| Device Name: | SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 -9308 |
| Contact | Marian D Harding |
| Correspondent | Marian D Harding ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 -9308 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-08 |
| Decision Date | 1991-11-01 |