The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Erika Hpf 200.
Device ID | K791321 |
510k Number | K791321 |
Device Name: | ERIKA HPF 200 |
Classification | Dialyzer, Capillary, Hollow Fiber |
Applicant | ERIKA, 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 | 1979-07-12 |
Decision Date | 1979-09-24 |