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 |