The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Model Triex-l Hollow Fiber Dialyzer.
Device ID | K800549 |
510k Number | K800549 |
Device Name: | MODEL TRIEX-L HOLLOW FIBER DIALYZER |
Classification | Dialyzer, Capillary, Hollow Fiber |
Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, 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 | 1980-03-10 |
Decision Date | 1980-04-10 |