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 |