The following data is part of a premarket notification filed by Gambro Renal Products, Inc. with the FDA for Molecular Adsorbent Recirculating(mars).
| Device ID | K113313 |
| 510k Number | K113313 |
| Device Name: | MOLECULAR ADSORBENT RECIRCULATING(MARS) |
| 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 | No |
| Date Received | 2011-11-09 |
| Decision Date | 2012-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37332414106950 | K113313 | 000 |