The following data is part of a premarket notification filed by Bourns Medical Systems, Inc. with the FDA for Flextubes:9, 20, 26.
| Device ID | K781428 |
| 510k Number | K781428 |
| Device Name: | FLEXTUBES:9, 20, 26 |
| Classification | Tubing, Pressure And Accessories |
| Applicant | BOURNS MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYX |
| CFR Regulation Number | 868.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-21 |
| Decision Date | 1978-09-11 |