The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Molecular Adsorbent Recirculating System (mars).
| Device ID | K033262 |
| 510k Number | K033262 |
| Device Name: | MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) |
| Classification | Apparatus, Hemoperfusion, Sorbent |
| Applicant | GAMBRO RENAL PRODUCTS 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Contact | Kae Miller |
| Correspondent | Kae Miller GAMBRO RENAL PRODUCTS 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Product Code | FLD |
| CFR Regulation Number | 876.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-10-09 |
| Decision Date | 2005-05-27 |
| Summary: | summary |