FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES
FDA 510(k) clearance K030497 · decided 2003-05-20
Clearance details
- K-number
- K030497
- Device name
- FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES
- Applicant
- Fresenius Medical Care
- Decision
- Substantially Equivalent
- Date received
- 2003-02-19
- Decision date
- 2003-05-20
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- KPO
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lexington, MA, US
- Third-party review
- No
- Expedited review
- No
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