The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Eri-flo 900 Dialyzer.
Device ID | K760702 |
510k Number | K760702 |
Device Name: | ERI-FLO 900 DIALYZER |
Classification | Dialyzer, Single Coil |
Applicant | ERIKA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FHS |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-22 |
Decision Date | 1976-11-19 |