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FDA 510(k), K113313, MOLECULAR ADSORBENT RECIRCULATING(MARS)
FDA 510(k), K113313, MOLECULAR ADSORBENT RECIRCULATING(MARS)
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510(K) Number: K113313
Device Name: MOLECULAR ADSORBENT RECIRCULATING(MARS)
Manufacturer: GAMBRO RENAL PRODUCTS, INC.
Device Classification Name: apparatus, hemoperfusion, sorbent
Regulation Number: 876.5870
Classification Product Code: FLD
Date Received: 11/09/2011
Decision Date: 12/14/2012
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: MOLECULAR ADSORBENT RECIRCULATING(MARS)
Manufacturer: GAMBRO RENAL PRODUCTS, INC.
Device Classification Name: apparatus, hemoperfusion, sorbent
Regulation Number: 876.5870
Classification Product Code: FLD
Date Received: 11/09/2011
Decision Date: 12/14/2012
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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