The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Fresenius Biocarb Hemodialysis Grade Sodium Bicarb.
| Device ID | K896111 |
| 510k Number | K896111 |
| Device Name: | FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Bruce Crook |
| Correspondent | Bruce Crook FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-23 |
| Decision Date | 1989-12-27 |