The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Polyflux Family Hemodialyzer/filter Labeled For Single And Multiple Use, Models 14l, 17l, 21l, 140h, 170h, 210h,6lr, 8lr.
| Device ID | K043342 |
| 510k Number | K043342 |
| Device Name: | POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | GAMBRO RENAL PRODUCTS 10810 WEST COLLINS AVE. Lakewood, CO 80215 |
| Contact | Kae Miller |
| Correspondent | Kae Miller GAMBRO RENAL PRODUCTS 10810 WEST COLLINS AVE. Lakewood, CO 80215 |
| Product Code | FJI |
| Subsequent Product Code | KDI |
| Subsequent Product Code | MSF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-06 |
| Decision Date | 2005-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37332414048199 | K043342 | 000 |
| 37332414031788 | K043342 | 000 |
| 37332414036141 | K043342 | 000 |
| 37332414036417 | K043342 | 000 |
| 37332414036424 | K043342 | 000 |
| 37332414037926 | K043342 | 000 |
| 37332414037933 | K043342 | 000 |
| 37332414041466 | K043342 | 000 |
| 37332414041473 | K043342 | 000 |
| 37332414047109 | K043342 | 000 |
| 37332414048182 | K043342 | 000 |
| 37332414031771 | K043342 | 000 |