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 |