GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR— 510(k) K023615
Substantially EquivalentGambro Renal Products
FDA 510(k) clearance K023615 for GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR, Substantially Equivalent on 2003-05-06. Applicant: Gambro Renal Products. Device class: 2.
Clearance details
- Applicant
- Gambro Renal Products
- Product code
- Code MSF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
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