The following data is part of a premarket notification filed by Seratronics, Inc. with the FDA for Fresenius Disposable Blood Lines.
| Device ID | K853851 |
| 510k Number | K853851 |
| Device Name: | FRESENIUS DISPOSABLE BLOOD LINES |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | SERATRONICS, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Scott N Walker |
| Correspondent | Scott N Walker SERATRONICS, INC. 4090 PIKE LN. Concord, CA 94520 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-16 |
| Decision Date | 1985-11-12 |