FDA 510(k), K133237, GEL-BEAD EMBOLIZATION SPHERES

FDA 510(k), K133237, GEL-BEAD EMBOLIZATION SPHERES

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510(K) Number: K133237
Device Name: GEL-BEAD EMBOLIZATION SPHERES
Manufacturer: ELLIE GILLESPIE
Device Classification Name: Device, Vascular, For Promoting Embolization
Regulation Number: KRD
Classification Product Code: 10/21/2013
Date Received: 04/25/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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