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FDA 510(k), K090357, HYDROFRAME (HES)
FDA 510(k), K090357, HYDROFRAME (HES)
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510(K) Number: K090357
Device Name: HYDROFRAME (HES)
Manufacturer: MICROVENTION, INC.
Device Classification Name: device, neurovascular embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 02/12/2009
Decision Date: 04/10/2009
Regulation Medical Specialty: Neurology
Device Name: HYDROFRAME (HES)
Manufacturer: MICROVENTION, INC.
Device Classification Name: device, neurovascular embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 02/12/2009
Decision Date: 04/10/2009
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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