The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Naturalyte Bicarbonate Dialysate Concen..
Device ID | K810925 |
510k Number | K810925 |
Device Name: | NATURALYTE BICARBONATE DIALYSATE CONCEN. |
Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
Applicant | ERIKA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KPO |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-06 |
Decision Date | 1981-04-23 |