The following data is part of a premarket notification filed by Fresenius Medical Care with the FDA for Fresenius Naturalyte Granuflo Dry Acid Concentrate 10xx Series, 24xx Series, 30xx Series.
| Device ID | K030497 |
| 510k Number | K030497 |
| Device Name: | FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | FRESENIUS MEDICAL CARE 95 HAYDEN AVE. Lexington, MA 02420 |
| Contact | Art Eilinsfeld |
| Correspondent | Art Eilinsfeld FRESENIUS MEDICAL CARE 95 HAYDEN AVE. Lexington, MA 02420 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-19 |
| Decision Date | 2003-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840861101603 | K030497 | 000 |
| 00840861101597 | K030497 | 000 |
| 00840861101580 | K030497 | 000 |
| 00840861101573 | K030497 | 000 |
| 00840861101542 | K030497 | 000 |
| 00840861101535 | K030497 | 000 |
| 00840861101528 | K030497 | 000 |
| 00840861101481 | K030497 | 000 |
| 00840861101474 | K030497 | 000 |