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 |