MOLECULAR ADSORBENT RECIRCULATING(MARS)— 510(k) K113313
Substantially EquivalentGambro Renal Products, Inc.
FDA 510(k) clearance K113313 for MOLECULAR ADSORBENT RECIRCULATING(MARS), Substantially Equivalent on 2012-12-14. Applicant: Gambro Renal Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Gambro Renal Products, Inc.
- 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
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