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FDA 510(k), K133237, GEL-BEAD EMBOLIZATION SPHERES
FDA 510(k), K133237, GEL-BEAD EMBOLIZATION SPHERES
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$89.00 USD
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$89.00 USD
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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: KXA
Date Received: 10/21/2013
Decision Date: 04/25/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: GEL-BEAD EMBOLIZATION SPHERES
Manufacturer: ELLIE GILLESPIE
Device Classification Name: Device, Vascular, For Promoting Embolization
Regulation Number: KRD
Classification Product Code: KXA
Date Received: 10/21/2013
Decision Date: 04/25/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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