The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Spiraflo Dialyzer, Disposable.
| Device ID | K760797 |
| 510k Number | K760797 |
| Device Name: | SPIRAFLO DIALYZER, DISPOSABLE |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-08 |
| Decision Date | 1976-11-19 |