The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 And 4000 Series.
| Device ID | K070177 |
| 510k Number | K070177 |
| Device Name: | FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 920 WINTER ST. Waltham, MA 02451 |
| Contact | Janet C Kay |
| Correspondent | Janet C Kay FRESENIUS MEDICAL CARE NORTH AMERICA 920 WINTER ST. 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 | 2007-01-18 |
| Decision Date | 2007-03-29 |
| Summary: | summary |