The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Dry Ac Acid Concentrate Mix For Bicarbonate Hemodialysis.
| Device ID | K011368 |
| 510k Number | K011368 |
| Device Name: | DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | GAMBRO RENAL PRODUCTS 1845 MASON AVE. Daytona Beach, FL 32117 -5102 |
| Contact | Fei Law |
| Correspondent | Fei Law GAMBRO RENAL PRODUCTS 1845 MASON AVE. Daytona Beach, FL 32117 -5102 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-04 |
| Decision Date | 2001-08-02 |