The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Hemodialysis (sps), Model 550, Code 5m1309.
| Device ID | K872364 |
| 510k Number | K872364 |
| Device Name: | HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 |
| Classification | System, Dialysate Delivery, Sealed |
| 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 | FII |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-18 |
| Decision Date | 1987-10-13 |