The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Cycler Sets Mod. #5c4143, 5c4144, 5c4145.
| Device ID | K791899 |
| 510k Number | K791899 |
| Device Name: | CYCLER SETS MOD. #5C4143, 5C4144, 5C4145 |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-25 |
| Decision Date | 1979-11-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412090097 | K791899 | 000 |
| 50085412007750 | K791899 | 000 |
| 50085412007415 | K791899 | 000 |