510(k) K971710
- Device
- ULTRACON ULTRAFILTRATOR
- Applicant
- QUANTIC BIOMEDICAL, INC.
- 510(k) number
- K971710
- Product code
- FJI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-02-27
- Date received
- 1997-05-08
- Regulation
- 876.5820
- Classification name
- Dialyzer, Capillary, Hollow Fiber
- 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
- ANDREW G HOOD
- Address
- 810 "E" St. San Rafael CA US 94901 94901
FDA Registration Numbers#
- 8030639
- 1721676
- 9611369
- 1713747
- 2028411
- 1225714
- 3038195011
- 1932668
Source Documents#
Other 510(k) Records For Product Code FJI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190459 | Hemoflow F3 and F4 Dialyzers | Fresenius Medical Care Renal Therapies Group, LLC | 2019-08-23 |
| K122952 | NIPRO PUREFLUX-L HEMODIALYZER | Nipro Medical Corporation | 2013-12-04 |
| K043342 | POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR | Gambro Renal Products | 2005-05-27 |
| K010366 | DISPOSABLE STORAGE CAP | Molded Products, Inc. | 2001-11-28 |
| K011148 | ULTRACONCENTRATOR SYSTEM | Interpore Cross Intl. | 2001-06-13 |
| K002761 | FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS | Fresenius Medical Care North America | 2000-12-04 |
| K991908 | IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS | Idemsa | 2000-04-17 |
| K992594 | A-15 HEMODIALYZER | Althin Medical AB | 1999-09-24 |
| K992565 | A-18 HEMODIALYZER | Althin Medical AB | 1999-09-23 |
| K991512 | ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X | Asahi Medical Co., Ltd. | 1999-07-29 |
| K990159 | DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 | Dynamic Technology Corp. | 1999-04-19 |
| K982337 | CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER | Haidylena Medical Egypt | 1998-12-29 |
| K981253 | ULTRACON ULTRAFILTRATOR | Interpore Intl. | 1998-12-11 |
| K980658 | PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 | Baxter Healthcare Corp | 1998-05-19 |
| K973291 | DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES | Dynamic Technology Corp. | 1997-12-19 |
Legacy Summary#
summary
FDA Review#
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