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FDA 510(k), K170150, Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags
FDA 510(k), K170150, Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags
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510(K) Number: K170150
Device Name: Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags
Manufacturer: Carmelo Gagliano
Device Classification Name: Set, Perfusion, Kidney, Disposable
Regulation Number: KDL
Classification Product Code: KXA
Date Received: 01/17/2017
Decision Date: 10/20/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags
Manufacturer: Carmelo Gagliano
Device Classification Name: Set, Perfusion, Kidney, Disposable
Regulation Number: KDL
Classification Product Code: KXA
Date Received: 01/17/2017
Decision Date: 10/20/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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