The following data is part of a premarket notification filed by Seratronics, Inc. with the FDA for Fresenius Hemoflow F6 And F8.
| Device ID | K870725 |
| 510k Number | K870725 |
| Device Name: | FRESENIUS HEMOFLOW F6 AND F8 |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | SERATRONICS, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Thomas E Cane |
| Correspondent | Thomas E Cane SERATRONICS, INC. 4090 PIKE LN. Concord, CA 94520 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-24 |
| Decision Date | 1987-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861100047 | K870725 | 000 |
| 10840861100030 | K870725 | 000 |