MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)— 510(k) K033262
Substantially EquivalentGambro Renal Products
FDA 510(k) clearance K033262 for MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS), Substantially Equivalent on 2005-05-27. Applicant: Gambro Renal Products. Device class: 2.
Clearance details
- Applicant
- Gambro Renal Products
- Product code
- Code FLD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5870
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
Recent devices under product code FLD
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- K984546 — BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
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More clearances from Gambro Renal Products
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