The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Flex Bubble Tubing.
| Device ID | K832865 |
| 510k Number | K832865 |
| Device Name: | FLEX BUBBLE TUBING |
| Classification | Tube, Aspirating, Flexible, Connecting |
| Applicant | SHERIDAN CATHETER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYY |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-23 |
| Decision Date | 1983-09-29 |