The following data is part of a premarket notification filed by Gambro Renal Products, Inc. with the FDA for Mars Monitor Itc Us, Mars Treatment Kit Type 1116/1 - X-mars Us, Prismaflex Control Unit.
Device ID | K133807 |
510k Number | K133807 |
Device Name: | MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT |
Classification | Apparatus, Hemoperfusion, Sorbent |
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 | FLD |
CFR Regulation Number | 876.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2013-12-16 |
Decision Date | 2014-03-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
37332414107728 | K133807 | 000 |