GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER— 510(k) K994390
Substantially EquivalentGambro Healthcare
FDA 510(k) clearance K994390 for GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER, Substantially Equivalent on 2000-10-26. Applicant: Gambro Healthcare. Device class: 2.
Clearance details
- Applicant
- Gambro Healthcare
- 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
Recent devices under product code MSF
view allMore clearances from Gambro Healthcare
view all- K990039 — GAMBRO DQM 200
- K982413 — COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS
- K982414 — GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
- K980386 — HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)
- K982760 — COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.