The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for B. Braun Bicarbonate Dialysate.
| Device ID | K041683 |
| 510k Number | K041683 |
| Device Name: | B. BRAUN BICARBONATE DIALYSATE |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Jennifer A Pung |
| Correspondent | Jennifer A Pung B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-21 |
| Decision Date | 2004-08-27 |
| Summary: | summary |