The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Tenckhoff Peritoneal Tubing Adapt..
| Device ID | K771428 |
| 510k Number | K771428 |
| Device Name: | TENCKHOFF PERITONEAL TUBING ADAPT. |
| Classification | Connector, Tubing, Dialysate |
| Applicant | QUINTON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKY |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-08-01 |
| Decision Date | 1977-10-18 |