The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Clirans Th10 Hollow Fiber Dialyzer.
Device ID | K802441 |
510k Number | K802441 |
Device Name: | CLIRANS TH10 HOLLOW FIBER DIALYZER |
Classification | Dialyzer, Capillary, Hollow Fiber |
Applicant | TERUMO AMERICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FJI |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-07 |
Decision Date | 1980-12-18 |