510(k) K974090
- Device
- 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
- Applicant
- FRESENIUS MEDICAL CARE NORTH AMERICA
- 510(k) number
- K974090
- Product code
- MSE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-08-27
- Date received
- 1997-10-29
- Regulation
- 876.5820
- Classification name
- Hemodialyzer, Re-use, Low Flux
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TOM FOLDEN
- Address
- 2637 Shadelands Dr. Walnut Creek CA US 94598 94598
FDA Registration Numbers#
- 1721676
Source Documents#
Other 510(k) Records For Product Code MSE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K001685 | PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 | Baxter Healthcare Corp | 2000-11-15 |
| K983720 | 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- | Asahi Medical Co., Ltd. | 1999-05-17 |
| K970700 | FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX | Fresenius USA, Inc. | 1998-09-15 |
| K970654 | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) | Baxter Healthcare Corp | 1997-11-12 |
| K970661 | CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) | Baxter Healthcare Corp | 1997-11-12 |
| K970650 | ASAHI AM-R SERIES DIALYZERS | Asahi Medical Co., Ltd. | 1997-09-30 |
Legacy Summary#
summary
FDA Review#
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