The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for External Y Valve 5c4198.
| Device ID | K870145 |
| 510k Number | K870145 |
| Device Name: | EXTERNAL Y VALVE 5C4198 |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake, IL 60073 |
| Contact | Robert L Wilkinson |
| Correspondent | Robert L Wilkinson TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake, IL 60073 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-13 |
| Decision Date | 1987-03-10 |