The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model 08-4000-lb.
| Device ID | K071387 |
| 510k Number | K071387 |
| Device Name: | FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451 |
| Contact | Janet C Kay |
| Correspondent | Janet C Kay FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-18 |
| Decision Date | 2007-06-15 |
| Summary: | summary |