Hemodialyzer, Re-Use, Low Flux
FDA product code MSE · 7 cleared devices
Class 2
Gastroenterology, Urology
- Regulation
- 21 CFR 876.5820
- Review panel
- GU
- Implant
- No
- Life sustaining
- Yes
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1997-09-30 – 2000-11-15
MSE
2000-11-15
MSE
1999-05-17
ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-
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MSE
1998-09-15
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
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MSE
1998-08-27
95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
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MSE
1997-11-12
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)
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MSE
1997-11-12
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
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MSE
1997-09-30
ASAHI AM-R SERIES DIALYZERS
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