The following data is part of a premarket notification filed by Gambro Renal Products, Inc. with the FDA for Prismaflex System 7.10.
| Device ID | K131516 |
| 510k Number | K131516 |
| Device Name: | PRISMAFLEX SYSTEM 7.10 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY SUITE 400 Lakewood, CO 80401 |
| Contact | Kae Miller |
| Correspondent | Kae Miller GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY SUITE 400 Lakewood, CO 80401 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-28 |
| Decision Date | 2014-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332414126766 | K131516 | 000 |
| 07332414124236 | K131516 | 000 |
| 07332414117702 | K131516 | 000 |