The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Cf 1211 Capillary Flow Dialyzer Code.
| Device ID | K822395 |
| 510k Number | K822395 |
| Device Name: | CF 1211 CAPILLARY FLOW DIALYZER CODE |
| Classification | Dialyzer, Disposable |
| Applicant | TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FJH |
| CFR Regulation Number | 876.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-11 |
| Decision Date | 1982-08-12 |