The following data is part of a premarket notification filed by Gambro Renal Products, Inc. with the FDA for Prismaflex M150 Set.
Device ID | K080519 |
510k Number | K080519 |
Device Name: | PRISMAFLEX M150 SET |
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 | 2008-02-25 |
Decision Date | 2008-06-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
37332414090006 | K080519 | 000 |