The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Gambro Prismaflex Hf1000 And Hf1400 Sets.
| Device ID | K042938 |
| 510k Number | K042938 |
| Device Name: | GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO RENAL PRODUCTS 10810 WEST COLLINS AVE. Lakewood, CO 80215 |
| Contact | Thomas B Dowell |
| Correspondent | Thomas B Dowell GAMBRO RENAL PRODUCTS 10810 WEST COLLINS AVE. Lakewood, CO 80215 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-25 |
| Decision Date | 2005-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37332414069316 | K042938 | 000 |
| 37332414069255 | K042938 | 000 |