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FDA 510(k), K203764, TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
FDA 510(k), K203764, TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
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$149.00 USD
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Sale price
$149.00 USD
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510(K) Number: K203764
Device Name: TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
Manufacturer: Kristin Ellis
Device Classification Name: Catheter, Percutaneous, Neurovasculature
Regulation Number: QJP
Classification Product Code: 12/23/2020
Date Received: 03/03/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
Manufacturer: Kristin Ellis
Device Classification Name: Catheter, Percutaneous, Neurovasculature
Regulation Number: QJP
Classification Product Code: 12/23/2020
Date Received: 03/03/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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