The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Spiraflow Dialyzers.
| Device ID | K772423 |
| 510k Number | K772423 |
| Device Name: | SPIRAFLOW DIALYZERS |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-28 |
| Decision Date | 1978-01-26 |