510(k) K113313 ยท FLD Apparatus, Hemoperfusion, Sorbent
MOLECULAR ADSORBENT RECIRCULATING(MARS)
| Applicant | Gambro Renal Products, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Dec 14, 2012 |
| Received | Nov 9, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113313
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.