The following data is part of a premarket notification filed by Concept, Inc. with the FDA for C-flex Penrose Drainage Tube.
| Device ID | K833061 |
| 510k Number | K833061 |
| Device Name: | C-FLEX PENROSE DRAINAGE TUBE |
| Classification | Tube, Drainage, Suprapubic |
| Applicant | CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FFA |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-09 |
| Decision Date | 1983-11-07 |