The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Catheter, Peritoneal Dialysis.
| Device ID | K760544 |
| 510k Number | K760544 |
| Device Name: | CATHETER, PERITONEAL DIALYSIS |
| Classification | Catheter, Peritoneal Dialysis, Single Use |
| Applicant | TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKO |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-08-30 |
| Decision Date | 1976-10-20 |