The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Capillary Flow Dialyzers Models St-12 & St-15.
| Device ID | K871471 |
| 510k Number | K871471 |
| Device Name: | CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| 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 | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-14 |
| Decision Date | 1987-06-12 |