The following data is part of a premarket notification filed by Gambro Renal Products, Inc. with the FDA for Prismaflex.
Device ID | K110823 |
510k Number | K110823 |
Device Name: | PRISMAFLEX |
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 | 2011-03-24 |
Decision Date | 2011-06-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07332414105266 | K110823 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRISMAFLEX 78861703 not registered Dead/Abandoned |
Gambro Lundia AB 2006-04-14 |
PRISMAFLEX 78859340 not registered Dead/Abandoned |
Gambro Lundia AB 2006-04-11 |
PRISMAFLEX 78513902 3102098 Live/Registered |
Gambro Lundia AB 2004-11-09 |
PRISMAFLEX 78272350 2979008 Live/Registered |
Gambro Lundia AB 2003-07-09 |
PRISMAFLEX 76290339 not registered Dead/Abandoned |
RIGIFLEX INTERNATIONAL 2001-07-26 |
PRISMAFLEX 76115953 2698334 Live/Registered |
Prismaflex USA, Inc 2000-08-24 |