BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE— 510(k) K930181
Substantially EquivalentFresenius USA, Inc.
FDA 510(k) clearance K930181 for BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE, Substantially Equivalent on 1995-11-29. Applicant: Fresenius USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Fresenius USA, Inc.
- Product code
- Code FKP
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walnut Creek, CA, US
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