The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Hollow Fiber Dialyzer.
Device ID | K843632 |
510k Number | K843632 |
Device Name: | HOLLOW FIBER DIALYZER |
Classification | Accessories, Blood Circuit, Hemodialysis |
Applicant | TRAVENOL LABORATORIES, S.A. Deerfield , IL 60015 - |
Contact | Julia Meyer |
Correspondent | Julia Meyer TRAVENOL LABORATORIES, S.A. Deerfield , IL 60015 - |
Product Code | KOC |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-17 |
Decision Date | 1984-10-18 |