GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING
FDA 510(k) clearance K911459 · decided 1991-07-17
Clearance details
- K-number
- K911459
- Device name
- GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING
- Applicant
- Fresenius USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-04-03
- Decision date
- 1991-07-17
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- KPO
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Concord, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank, Model recall (Z-2226-2010) | Fresenius Medical Care North America | 2010-08-15 |